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818 dated events across 251 products, including 273 approvals and 238 accelerated approvals of which 138 have been confirmed, plus designations, filings, complete response letters, withdrawals, and label changes. Sort by date, filter by type or region, and click through to the product. The FDA approvals feed below is refreshed weekly and shows what is new since the last build and what is not yet in the corpus.
20 notifications from the Oncology Center of Excellence since 2026-06-02; 2 new since the last snapshot. 4 are not yet recorded as regulatory events on the product page.
Every FDA oncology notice in the window matched a product in OnCo.
246 approved submissions for corpus products since 2026-06-02, from openFDA drugsfda. Efficacy and labelling supplements are listed; manufacturing and REMS changes are not.
| What happened | ||||
|---|---|---|---|---|
| 14 Nov 2026 | Ivonescimab Bispecific antibody (PD-1×VEGF) | PDUFA date | US | PDUFA target date source |
| 24 Sept 2026 | Approval | US | With lenvatinib, advanced renal cell carcinoma with a clear cell component source | |
| 24 Sept 2026 | Approval | US | With belzutifan, advanced renal cell carcinoma with a clear cell component source | |
| 23 Sept 2026 | Galleri Multi-cancer early detection blood test | Advisory committee | US | FDA Molecular and Clinical Genetics Panel meeting source |
| 23 Sept 2026 | Approval | US | Previously treated unresectable, locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement (REFOCUS) source | |
| 18 Sept 2026 | Approval | US | With imlunestrant, for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer source | |
| 18 Sept 2026 | Approval | US | With abemaciclib, for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer source | |
| 9 Sept 2026 | Accelerated approval | US | Treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized testFDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous non-small cell lung cancer The confirmatory requirement was still open 0.0 years later, when the FDA's table was read. source | |
| 4 Sept 2026 | Accelerated approval | US | In combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized testAccelerated approval (Etcamah) The confirmatory requirement was still open 0.0 years later, when the FDA's table was read. source | |
| 1 Sept 2026 | Withdrawal | US | In combination with cetuximab for the treatment of adult patients with KRAS G12C mutated locally advanced or metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.Withdrawn: the indication came off the label 2.3 years after its accelerated approval. source | |
| 28 Aug 2026 | 177Lu-edotreotide Radioligand therapy (beta) | PDUFA date | US | PDUFA goal date for GEP-NET indication source |
| 26 Aug 2026 | Approval | US | NDA 220910 approved as Rasonque: adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy source | |
| 25 Aug 2026 | Approval | US | FDA approves zanidatamab-hrii and tislelizumab-jsgr for HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma source | |
| 25 Aug 2026 | Approval | US | First-line HER2-positive gastric, gastro-oesophageal junction or oesophageal adenocarcinoma with tislelizumab and fluoropyrimidine-platinum chemotherapy source | |
| 19 Aug 2026 | Intismeran autogene Personalised mRNA neoantigen vaccine | Filing / deal | US | Phase 3 INTerpath-001 met RFS and DMFS endpoints; filings to follow source |
| 13 Aug 2026 | Approval | US | FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma source | |
| 13 Aug 2026 | Approval | US | FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma source | |
| 13 Aug 2026 | Accelerated approval | US | In combination with daratumumab and hyaluronidase-fihj and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agentFDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma The confirmatory requirement was still open 0.1 years later, when the FDA's table was read. source | |
| 6 Aug 2026 | Approval | US | Accelerated approval of vusolimogene oderparepvec in combination with nivolumab, unresectable advanced cutaneous melanoma source | |
| 6 Aug 2026 | Accelerated approval | US | In combination with nivolumab for treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimenAccelerated approval with nivolumab for unresectable/metastatic melanoma after anti-PD-1 (IGNYTE) The confirmatory requirement was still open 0.1 years later, when the FDA's table was read. source | |
| 31 Jul 2026 | Approval | US | PSMA+ metastatic hormone-sensitive prostate cancer with ARPI (PSMAddition) source | |
| 30 Jul 2026 | Selinexor Small-molecule XPO1 (nuclear export) inhibitor | Filing / deal | US | XPORT-EC-042 misses primary endpoint; endometrial development deprioritised source |
| 23 Jul 2026 | Camrelizumab + rivoceranib PD-1 antibody + oral VEGFR2 inhibitor | Complete response letter | US | Third CRL, again cGMP source |
| 22 Jul 2026 | Approval | US | ROS1+ NSCLC after at least one prior ROS1 TKI (ARROS-1) source | |
| 17 Jul 2026 | Filing / deal | US | NDA 220910 received by the FDA on the RASolute 302 result source | |
| Jul 2026 | Approval | US | Subcutaneous on-body injector | |
| Jul 2026 | Designation | US | Commissioner's National Priority Voucher (CNPV) awarded source | |
| 14 Jul 2026 | Approval | US | FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer source | |
| 14 Jul 2026 | Approval | US | HR+/HER2- advanced breast cancer after CDK4/6 inhibitor with palbociclib and fulvestrant (VIKTORIA-1) source | |
| 14 Jul 2026 | Approval | US | Gedatolisib with fulvestrant, with or without palbociclib, HR+/HER2- advanced breast cancer (VIKTORIA-1) source | |
| 14 Jul 2026 | Confirmed | US | Adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options *Traditional approval, locally advanced or metastatic RET fusion-positive solid tumours source | |
| 14 Jul 2026 | Confirmed | US | Formulation: Adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment optionsConfirmed: the accelerated approval of 2024 converted to traditional approval 2.3 years after it was granted. | |
| 10 Jul 2026 | Approval | US | Muscle-invasive bladder cancer with pembrolizumab, with or without berahyaluronidase alfa source | |
| 10 Jul 2026 | Approval | US | Muscle-invasive bladder cancer with enfortumab vedotin, as pembrolizumab or pembrolizumab with berahyaluronidase alfa source | |
| 9 Jul 2026 | Approval | US | FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications source | |
| 30 Jun 2026 | Allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldqFDA 2026-06-30 Precision-sorted allogeneic stem cell graft with regulatory T cells | Approval | US | FDA approves allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq (Tregzi, Orca Bio) on the Precision-T trial source |
| 2026 | Cretostimogene grenadenorepvec Oncolytic adenovirus (intravesical) | Filing / deal | US | Rolling BLA initiated; completion expected Q4 2026 source |
| 2026 | Fianlimab Monoclonal antibody (anti-LAG-3) | Designation | US | First-line metastatic phase 3 missed its primary PFS endpoint (Regeneron release) |
| 25 Jun 2026 | Tacquell (autologous melanoma-derived tumour-infiltrating lymphocytes) TIL cell therapy (autologous tumour-infiltrating lymphocytes, ex vivo expanded) | Complete response letter | EU | CHMP negative opinion on Tacquell (autologous TIL) for melanoma; applicant Netherlands Cancer Institute source |
| 24 Jun 2026 | Approval | US | Maintenance in HR+/HER2+ advanced breast cancer with anti-HER2 and endocrine therapy (PATINA) source | |
| 24 Jun 2026 | Approval | US | First-line PD-L1+ TNBC with sacituzumab govitecan (ASCENT-04) source | |
| 24 Jun 2026 | Approval | US | FDA approves palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive metastatic breast cancer source | |
| 24 Jun 2026 | Approval | US | First-line metastatic TNBC: monotherapy (PD-1 ineligible, ASCENT-03) and with pembrolizumab (CPS ≥10, ASCENT-04) source | |
| 24 Jun 2026 | Approval | US | FDA approves palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive metastatic breast cancer source | |
| 22 Jun 2026 | Tazemetostat Small-molecule EZH2 inhibitor | Withdrawal | US | Treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resectionWithdrawn: the indication came off the label 6.4 years after its accelerated approval. source |
| 22 Jun 2026 | Tazemetostat Small-molecule EZH2 inhibitor | Withdrawal | US | Treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies. Treatment of adult patients with R/R FL who have no satisfactory alternative treatment optionsWithdrawn: the indication came off the label 6.0 years after its accelerated approval. source |
| 12 Jun 2026 | Approval | US | Capivasertib approved for use with abiraterone and prednisone in PTEN-deficient metastatic prostate cancer (CAPItello-281); abiraterone itself was already approved source | |
| 12 Jun 2026 | Approval | US | Adjuvant clear-cell RCC with pembrolizumab (LITESPARK-022) source | |
| 12 Jun 2026 | Approval | US | PTEN-deficient metastatic prostate cancer with abiraterone (CAPItello-281) source | |
| 12 Jun 2026 | Approval | US | Adjuvant RCC with belzutifan (LITESPARK-022) source | |
| 12 Jun 2026 | Approval | US | FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer source | |
| 28 May 2026 | Approval | US | High-risk non-muscle-invasive bladder cancer with BCG (POTOMAC) source | |
| 27 May 2026 | Pivekimab sunirine ADC (anti-CD123 antibody, IGN payload) | Approval | US | FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare hematologic malignancy source |
| 22 May 2026 | Approval | US | First-line unresectable/metastatic TNBC, PD-1/PD-L1 inhibitor ineligible (TROPION-Breast02) source | |
| Q2 2026 | Afamitresgene autoleucel TCR-T (MAGE-A4) | Label change | US | Label extended to patients aged 12 and older source |
| May 2026 | ArteraAI Breast AI digital pathology risk test | Approval | US | FDA clearance: first digital-pathology-based risk stratification tool for early HR+/HER2- breast cancer source |
| Q2 2026 | Atezolizumab Monoclonal antibody (anti-PD-L1) | Approval | US | Adjuvant ctDNA-positive muscle-invasive bladder cancer (IMvigor011): first ctDNA-guided indication source |
| Q2 2026 | Signatera Tumour-informed ctDNA MRD test | Label change | US | Used to select ctDNA-positive patients in the first ctDNA-guided drug approval (IMvigor011, atezolizumab) source |
| Q2 2026 | Approval | US | Early-stage HER2+ breast cancer: neoadjuvant (DESTINY-Breast11) and post-neoadjuvant residual disease (DESTINY-Breast05) source | |
| Q2 2026 | Label change | US | Displaced post-neoadjuvantly by T-DXd approval (DESTINY-Breast05) source | |
| Q2 2026 | Vepdegestrant PROTAC oestrogen receptor degrader | Approval | US | ESR1-mutated ER+/HER2- advanced breast cancer after endocrine therapy: first PROTAC approved source |
| Q2 2026 | Zenocutuzumab Bispecific antibody (HER2×HER3) | Approval | US | NRG1-fusion cholangiocarcinoma source |
| 13 May 2026 | Decitabine + cedazuridine (oral) Oral hypomethylating agent | Approval | US | With venetoclax in newly diagnosed unfit AML source |
| 13 May 2026 | Sonrotoclax Small-molecule BCL-2 inhibitor (second generation) | Accelerated approval | US | Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.Accelerated approval in MCL; priority review, Project Orbis The confirmatory requirement was still open 0.3 years later, when the FDA's table was read. source |
| 30 Apr 2026 | Advisory committee | US | ODAC voted 6-3 against (clinical relevance of ctDNA-triggered switch) source | |
| 30 Apr 2026 | Selinexor Small-molecule XPO1 (nuclear export) inhibitor | Withdrawal | US | Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma (FL), after at least 2 lines of systemic therapy.Withdrawn: the indication came off the label 5.9 years after its accelerated approval. source |
| 1 Apr 2026 | Brexucabtagene autoleucel Autologous CD19 CAR-T (CD28 costimulatory domain) | Confirmed | US | Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).Confirmed: the accelerated approval of 2020 converted to traditional approval 5.7 years after it was granted. |
| 20 Mar 2026 | Confirmed | US | For the treatment of classical Hodgkin Lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotinConfirmed: the accelerated approval of 2016 converted to traditional approval 9.8 years after it was granted. | |
| 20 Mar 2026 | Confirmed | US | Treatment of adult patients with classical Hodgkin lymphoma that has relapsed or progressed after: Autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, Or 3 or more lines of systemic therapy that includes autologous HSCTConfirmed: the accelerated approval of 2017 converted to traditional approval 8.9 years after it was granted. | |
| Mar 2026 | Approval | US | First-line advanced classical Hodgkin lymphoma with AVD, age ≥12 (SWOG S1826) source | |
| Mar 2026 | Tafasitamab Monoclonal antibody (anti-CD19, Fc-enhanced) | Filing / deal | US | sBLA for frontline high-risk DLBCL (frontMIND) planned H1 2026 source |
| Mar 2026 | Tazemetostat Small-molecule EZH2 inhibitor | Withdrawal | Global | Withdrawn over secondary haematologic malignancies |
| Mar 2026 | Zelenectide pevedotin Bicycle toxin conjugate (Nectin-4, MMAE) | Withdrawal | US | Programme deprioritised after regulatory feedback on Duravelo-2 design source |
| 9 Mar 2026 | Giredestrant Oral SERD | Designation | Global | persevERA primary endpoint not met source |
| 9 Mar 2026 | Piflufolastat F-18 / Pylarify TruVu PET imaging agent | Approval | US | Pylarify TruVu formulation source |
| 5 Mar 2026 | Approval | US | Teclistamab + daratumumab after ≥1 prior line source | |
| 5 Mar 2026 | Teclistamab Bispecific T-cell engager (BCMA×CD3) | Confirmed | US | Adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibodyConfirmed: the accelerated approval of 2022 converted to traditional approval 3.4 years after it was granted. |
| 26 Feb 2026 | Izalontamab brengitecan Bispecific ADC | Filing / deal | China | Positive interim phase 3 in pretreated TNBC (BL-B01D1-307) announced; regulatory submissions follow source |
| 26 Feb 2026 | Accelerated approval | US | Treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized testAccelerated approval on a surrogate endpoint; the confirmatory requirement was still open 0.6 years later, when the FDA's table was read. source | |
| 24 Feb 2026 | Encorafenib Small-molecule kinase inhibitor (BRAF) | Confirmed | US | In combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved testConfirmed: the accelerated approval of 2024 converted to traditional approval 1.2 years after it was granted. source |
| 20 Feb 2026 | Lisocabtagene maraleucel CAR-T (CD19, defined CD4:CD8) | Confirmed | US | Adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapyConfirmed: the accelerated approval of 2024 converted to traditional approval 1.8 years after it was granted. source |
| 19 Feb 2026 | Acalabrutinib Small-molecule covalent BTK inhibitor (second generation) | Approval | US | Acalabrutinib + venetoclax fixed duration (AMPLIFY) source |
| 19 Feb 2026 | Giredestrant Oral SERD | Filing / deal | US | NDA accepted (evERA, ESR1-mutant) source |
| Feb 2026 | Anitocabtagene autoleucel CAR-T (BCMA, D-domain binder) | Filing / deal | US | BLA accepted; PDUFA 27 December 2026 source |
| Feb 2026 | Atirmociclib Small-molecule CDK4-selective inhibitor | Designation | Global | Positive topline phase 2 FOURLIGHT-1 source |
| Q1 2026 | Encorafenib Small-molecule kinase inhibitor (BRAF) | Approval | US | Full approval in first-line BRAF V600E mCRC with OS benefit source |
| Q1 2026 | Optune / Optune Pax (TTFields) Device (tumour treating fields) | Approval | US | Optune Pax, locally advanced pancreatic cancer with chemotherapy (PANOVA-3) source |
| Q1 2026 | Approval | US | Platinum-resistant PD-L1+ ovarian cancer source | |
| Q1 2026 | Relacorilant Small-molecule glucocorticoid receptor antagonist | Approval | US | Platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer with nab-paclitaxel source |
| Q1 2026 | Teclistamab Bispecific T-cell engager (BCMA×CD3) | Approval | US | Relapsed/refractory myeloma after ≥1 prior line, with daratumumab (MajesTEC-3) source |
| Q1 2026 | Approval | US | First-line HER2-mutant non-squamous NSCLC source | |
| 30 Jan 2026 | Camrelizumab + rivoceranib PD-1 antibody + oral VEGFR2 inhibitor | Filing / deal | US | Resubmission accepted; PDUFA 23 July 2026 source |
| 29 Jan 2026 | Galleri Multi-cancer early detection blood test | Filing / deal | US | Final PMA module submitted source |
| 16 Jan 2026 | Filing / deal | US | EPCORE DLBCL-1 topline: PFS met, OS (US primary endpoint) not met source | |
| Jan 2026 | Ivonescimab Bispecific antibody (PD-1×VEGF) | Filing / deal | US | BLA submitted by Summit for EGFR-mutant NSCLC after TKI (HARMONi) source |
| 19 Dec 2025 | Accelerated approval | US | Formulation: Treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 0.7 years later, when the FDA's table was read. | |
| 17 Dec 2025 | Retifanlimab Anti-PD-1 monoclonal antibody (IgG4) | Confirmed | US | Adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC)Confirmed: the accelerated approval of 2023 converted to traditional approval 2.7 years after it was granted. source |
| 17 Dec 2025 | Rucaparib Small-molecule PARP inhibitor | Confirmed | US | Treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapyConfirmed: the accelerated approval of 2020 converted to traditional approval 5.6 years after it was granted. source |
| Dec 2025 | Filing / deal | China | First-line urothelial cancer with toripalimab, positive phase 3 source | |
| Dec 2025 | Approval | US | Full approval based on DeLLphi-304 source | |
| Dec 2025 | Filing / deal | US | First-line HER2+ gastro-oesophageal adenocarcinoma (HERIZON-GEA-01) submission source | |
| 3 Dec 2025 | Pirtobrutinib Small-molecule non-covalent (reversible) BTK inhibitor | Approval | US | Traditional approval; label broadened to any prior covalent BTKi source |
| 2 Dec 2025 | Pirtobrutinib Small-molecule non-covalent (reversible) BTK inhibitor | Confirmed | US | Adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitorConfirmed: the accelerated approval of 2023 converted to traditional approval 2.0 years after it was granted. source |
| 19 Nov 2025 | Confirmed | US | Treatment of patients with light chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide and dexamethasone in newly diagnosed patientsConfirmed: the accelerated approval of 2021 converted to traditional approval 4.8 years after it was granted. source | |
| 19 Nov 2025 | Accelerated approval | US | Treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapyAccelerated approval on a surrogate endpoint; the confirmatory requirement was still open 0.8 years later, when the FDA's table was read. source | |
| 19 Nov 2025 | Confirmed | US | Adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapyConfirmed: the accelerated approval of 2024 converted to traditional approval 1.5 years after it was granted. source | |
| 18 Nov 2025 | Confirmed | US | Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapyConfirmed: the accelerated approval of 2024 converted to traditional approval 1.4 years after it was granted. source | |
| Nov 2025 | Approval | US | Perioperative gastric/GEJ cancer with FLOT (MATTERHORN) source | |
| Q4 2025 | Filing / deal | US | Muscle-invasive bladder cancer (EV-303/304) submissions following positive results source | |
| 13 Nov 2025 | Ziftomenib Small-molecule menin inhibitor | Approval | US | KOMET-001; priority review source |
| 27 Oct 2025 | Confirmed | US | Formulation: As monotherapy or as monotherapy following treatment with intravenous nivolumab and ipilimumab combination therapy for the treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan .Confirmed: the accelerated approval of 2024 converted to traditional approval 0.8 years after it was granted. source | |
| 27 Oct 2025 | Confirmed | US | Formulation: Treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib and following treatment with intravenous nivolumab and ipilimumab .Confirmed: the accelerated approval of 2024 converted to traditional approval 0.8 years after it was granted. source | |
| Oct 2025 | Approval | US | Approval in combination regimens for relapsed/refractory myeloma after ≥1 line (DREAMM-7/8) source | |
| Oct 2025 | Approval | US | Adjuvant high-risk CSCC after surgery and radiation (C-POST) source | |
| Oct 2025 | Revumenib Small-molecule menin inhibitor | Approval | US | Relapsed/refractory NPM1-mutant AML source |
| 2 Oct 2025 | Lurbinectedin Cytotoxic (transcription inhibitor) | Approval | US | Full approval with atezolizumab as first-line maintenance (IMforte) source |
| 25 Sept 2025 | Approval | US | Approved as Inluriyo source | |
| 19 Sept 2025 | Accelerated approval | US | Formulation: Treatment of adult and pediatric patients 12 years and older with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options .Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 1.0 year later, when the FDA's table was read. source | |
| Sept 2025 | Amivantamab Bispecific antibody (EGFR×MET) | Approval | US | Subcutaneous formulation (PALOMA-3) source |
| Sept 2025 | Approval | US | Subcutaneous pembrolizumab (Keytruda Qlex) source | |
| Sept 2025 | Satricabtagene autoleucel CAR-T (Claudin 18.2) | Approval | China | First CAR-T approved for a solid tumour (CLDN18.2+ gastric/GEJ adenocarcinoma) source |
| 9 Sept 2025 | Gemcitabine intravesical system (TAR-200) Intravesical drug-eluting device | Approval | US | FDA approval of Inlexzo source |
| Aug 2025 | Afamitresgene autoleucel TCR-T (MAGE-A4) | Filing / deal | US | US rights sold by Adaptimmune to US WorldMeds source |
| 14 Aug 2025 | ArteraAI Prostate AI digital pathology prognostic/predictive test | Approval | US | De novo authorisation: first AI pathology test cleared for prognostic and predictive use in localised prostate cancer source |
| 8 Aug 2025 | Accelerated approval | US | Treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA approved test, and who have received prior systemic therapyAccelerated approval, previously treated HER2-mutant non-squamous NSCLC (Beamion LUNG-1) The confirmatory requirement was still open 1.1 years later, when the FDA's table was read. source | |
| 6 Aug 2025 | Dordaviprone Small-molecule imipridone (ClpP agonist / DRD2 antagonist) | Accelerated approval | US | Treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 1.1 years later, when the FDA's table was read. source |
| 4 Aug 2025 | Letetresgene autoleucel TCR-T (NY-ESO-1) | Filing / deal | US | Asset transferred to US WorldMeds; BLA committed by end-2026 |
| 30 Jul 2025 | Odronextamab Bispecific T-cell engager (CD20×CD3) | Approval | US | Accelerated approval in follicular lymphoma |
| 23 Jul 2025 | Complete response letter | US | Complete response letter on combination filing; resubmitted source | |
| 22 Jul 2025 | Complete response letter | US | Complete response letter citing trial design and heterogeneity source | |
| 2 Jul 2025 | Complete response letter | US | Complete response letter for STARGLO combination (regional heterogeneity); approved in EU source | |
| 2 Jul 2025 | Accelerated approval | US | Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.Accelerated approval (LINKER-MM1) The confirmatory requirement was still open 1.2 years later, when the FDA's table was read. source | |
| 2 Jul 2025 | Sunvozertinib Small-molecule EGFR exon 20 insertion TKI (irreversible) | Accelerated approval | US | Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved testAccelerated approval on a surrogate endpoint; the confirmatory requirement was still open 1.2 years later, when the FDA's table was read. source |
| 2025 | Eflornithine (DFMO) Small-molecule ornithine decarboxylase inhibitor | Filing / deal | EU | MAA submitted to EMA, UK, Australia, Switzerland source |
| 2025 | Approval | EU | European Commission approval source | |
| 2025 | Designation | US | Breakthrough Therapy designation, advanced endometrial cancer after PD-(L)1 and platinum source | |
| 2025 | Serplulimab Monoclonal antibody (anti-PD-1) | Approval | UK | MHRA approval source |
| 27 Jun 2025 | Tisagenlecleucel CAR-T (CD19) | Label change | US | REMS requirements removed for approved CAR-T products |
| 23 Jun 2025 | Accelerated approval | US | Treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.EGFR-mutant NSCLC after TKI and platinum chemotherapy (accelerated) The confirmatory requirement was still open 1.2 years later, when the FDA's table was read. source | |
| Jun 2025 | Approval | US | Full approval in NSCLC (KRYSTAL-12) source | |
| Jun 2025 | Ciltacabtagene autoleucel CAR-T (BCMA) | Label change | US | REMS requirements removed for CAR-T class source |
| Jun 2025 | Dostarlimab Monoclonal antibody (anti-PD-1) | Designation | US | Breakthrough Therapy designation, dMMR locally advanced rectal cancer (organ preservation) source |
| Jun 2025 | Inavolisib Small-molecule PI3Kα inhibitor and degrader | Label change | US | OS benefit added to label source |
| Jun 2025 | Lifileucel TIL cell therapy | Approval | EU | Conditional marketing authorisation source |
| Jun 2025 | Relacorilant Small-molecule glucocorticoid receptor antagonist | Filing / deal | US | NDA submitted (ROSELLA) source |
| Jun 2025 | Shield Blood-based colorectal cancer screening test | Designation | US | Breakthrough Device designation for Shield multi-cancer (MCD) source |
| Jun 2025 | Filing / deal | US | Phase 3 DeLLphi-304 OS benefit presented; conversion to full approval pursued source | |
| Jun 2025 | Vepdegestrant PROTAC oestrogen receptor degrader | Filing / deal | US | NDA submitted (VERITAC-2) source |
| Jun 2025 | Approval | EU | EMA approval source | |
| 10 Jun 2025 | Zanubrutinib Small-molecule covalent BTK inhibitor (second generation) | Accelerated approval | US | Formulation: Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 1.3 years later, when the FDA's table was read. |
| 10 Jun 2025 | Zanubrutinib Small-molecule covalent BTK inhibitor (second generation) | Accelerated approval | US | Formulation: Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 1.3 years later, when the FDA's table was read. |
| 10 Jun 2025 | Zanubrutinib Small-molecule covalent BTK inhibitor (second generation) | Accelerated approval | US | Formulation: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy.Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 1.3 years later, when the FDA's table was read. |
| 1 Jun 2025 | Filing / deal | US | NDA based on SERENA-6 | |
| 22 May 2025 | Resminostat Small-molecule HDAC inhibitor | Complete response letter | EU | CHMP negative opinion on Kinselby (resminostat) for advanced mycosis fungoides and Sézary syndrome source |
| May 2025 | Approval | US | Pheochromocytoma/paraganglioma source | |
| May 2025 | Designation | US | Breakthrough Therapy designation, PIK3CA-wild-type HR+/HER2- breast cancer after CDK4/6 source | |
| May 2025 | Withdrawal | US | BLA withdrawn after HERTHENA-Lung02 met PFS but not OS source | |
| May 2025 | Approval | China | HER2-mutant NSCLC source | |
| 14 May 2025 | Accelerated approval | US | Treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy.Accelerated approval, previously treated c-MET-high non-squamous NSCLC (LUMINOSITY) The confirmatory requirement was still open 1.3 years later, when the FDA's table was read. source | |
| 8 May 2025 | Avutometinib + defactinib Small-molecule RAF/MEK clamp + FAK inhibitor | Accelerated approval | US | Treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapyAccelerated approval on RAMP 201; RAMP 301 confirmatory The confirmatory requirement was still open 1.4 years later, when the FDA's table was read. source |
| Apr 2025 | Approval | US | With nivolumab first-line MSI-H/dMMR colorectal cancer (CheckMate 8HW) source | |
| Apr 2025 | Ivonescimab Bispecific antibody (PD-1×VEGF) | Approval | China | First-line PD-L1+ NSCLC (HARMONi-2) source |
| 11 Apr 2025 | Confirmed | US | In combination with nivolumab, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenibConfirmed: the accelerated approval of 2020 converted to traditional approval 5.1 years after it was granted. | |
| 11 Apr 2025 | Confirmed | US | In combination with ipilimumab, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenibConfirmed: the accelerated approval of 2020 converted to traditional approval 5.1 years after it was granted. | |
| 9 Apr 2025 | Larotrectinib Small-molecule pan-TRK inhibitor (first generation) | Confirmed | US | Treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have no satisfactory alternative treatments or that have progressed following treatmentConfirmed: the accelerated approval of 2018 converted to traditional approval 6.4 years after it was granted. source |
| 9 Apr 2025 | Larotrectinib Small-molecule pan-TRK inhibitor (first generation) | Confirmed | US | Formation: Treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have no satisfactory alternative treatments or that have progressed following treatmentConfirmed: the accelerated approval of 2018 converted to traditional approval 6.4 years after it was granted. source |
| 8 Apr 2025 | Confirmed | US | In combination with nivolumab, is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or DNA mismatch repair deficient (dMMR), metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecanConfirmed: the accelerated approval of 2018 converted to traditional approval 6.7 years after it was granted. | |
| 8 Apr 2025 | Confirmed | US | For the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecanConfirmed: the accelerated approval of 2017 converted to traditional approval 7.7 years after it was granted. | |
| 8 Apr 2025 | Confirmed | US | In combination with ipilimumab, is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or DNA mismatch repair deficient (dMMR), metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecanConfirmed: the accelerated approval of 2018 converted to traditional approval 6.7 years after it was granted. | |
| 28 Mar 2025 | Approval | US | Perioperative muscle-invasive bladder cancer (NIAGARA) source | |
| 28 Mar 2025 | Approval | US | PSMA+ mCRPC after ARPI, before chemotherapy (PSMAfore) source | |
| 26 Mar 2025 | Approval | US | NET indication on CABINET source | |
| 19 Mar 2025 | Confirmed | US | In combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma 1Confirmed: the accelerated approval of 2021 converted to traditional approval 3.9 years after it was granted. source | |
| Mar 2025 | 177Lu-edotreotide Radioligand therapy (beta) | Designation | US | COMPETE topline at ENETS 2025 source |
| Mar 2025 | AK146D1 Bispecific ADC | Filing / deal | China | IND cleared; first-in-human phase 1 started source |
| Mar 2025 | Camrelizumab Monoclonal antibody (anti-PD-1) | Complete response letter | US | Second complete response letter |
| Mar 2025 | Camrelizumab + rivoceranib PD-1 antibody + oral VEGFR2 inhibitor | Complete response letter | US | Second CRL |
| Mar 2025 | Approval | JP | First approval worldwide for HR+/HER2- breast cancer (December 2024, Japan MHLW) source | |
| Mar 2025 | Approval | China | EGFR-mutant NSCLC after TKI failure source | |
| 4 Mar 2025 | Approval | US | First-line ESCC PD-L1 ≥1% (RATIONALE-306) | |
| Feb 2025 | Serplulimab Monoclonal antibody (anti-PD-1) | Approval | EU | European Commission approval for ES-SCLC source |
| Feb 2025 | Filing / deal | China | Phase 3 vs T-DM1 in residual disease registered (NCT06830889) source | |
| 14 Feb 2025 | Approval | US | MOTION source | |
| 27 Jan 2025 | Approval | US | HER2-low and HER2-ultralow HR+ breast cancer after endocrine therapy (DESTINY-Breast06) source | |
| 17 Jan 2025 | Approval | US | HR+/HER2- metastatic breast cancer after endocrine therapy and chemotherapy (TROPION-Breast01) source | |
| 16 Jan 2025 | Acalabrutinib Small-molecule covalent BTK inhibitor (second generation) | Confirmed | US | Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapyConfirmed: the accelerated approval of 2017 converted to traditional approval 7.2 years after it was granted. |
| 16 Jan 2025 | Sotorasib Small-molecule inhibitor (KRAS G12C) | Approval | US | KRAS G12C colorectal cancer with panitumumab (CodeBreaK 300) source |
| Jan 2025 | Panitumumab Monoclonal antibody (anti-EGFR) | Approval | US | With sotorasib for KRAS G12C mCRC (CodeBreaK 300) |
| 27 Dec 2024 | Accelerated approval | US | Formulation: As monotherapy or as monotherapy following treatment with intravenous nivolumab and ipilimumab combination therapy for the treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan .Subcutaneous nivolumab (Opdivo Qvantig) source | |
| 27 Dec 2024 | Accelerated approval | US | Formulation: Treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib and following treatment with intravenous nivolumab and ipilimumab .Accelerated approval on a surrogate endpoint, with a confirmatory trial required. source | |
| 20 Dec 2024 | Encorafenib Small-molecule kinase inhibitor (BRAF) | Accelerated approval | US | In combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved testFirst-line BRAF V600E mCRC with cetuximab and mFOLFOX6 (BREAKWATER, accelerated) source |
| Dec 2024 | Approval | US | First-line gastric/GEJ (RATIONALE-305) | |
| 13 Dec 2024 | Approval | US | Approved for cSCC | |
| 4 Dec 2024 | Approval | US | Limited-stage SCLC after chemoradiation (ADRIATIC) source | |
| 4 Dec 2024 | Zenocutuzumab Bispecific antibody (HER2×HER3) | Accelerated approval | US | Treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.Accelerated approval, NRG1-fusion NSCLC and pancreatic adenocarcinoma (eNRGy): first therapy for NRG1 fusions The confirmatory requirement was still open 1.8 years later, when the FDA's table was read. source |
| 4 Dec 2024 | Zenocutuzumab Bispecific antibody (HER2×HER3) | Accelerated approval | US | Treatment of adults with advanced unresectable or metastatic nonsmall cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 1.8 years later, when the FDA's table was read. source |
| 3 Dec 2024 | Designation | US | Breakthrough Therapy designation, EGFR-mutant NSCLC after TKI source | |
| 22 Nov 2024 | Withdrawal | US | Treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitorWithdrawn: the indication came off the label 3.6 years after its accelerated approval. source | |
| 20 Nov 2024 | Accelerated approval | US | Treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved testAccelerated approval, previously treated HER2+ (IHC3+) biliary tract cancer (HERIZON-BTC-01) The confirmatory requirement was still open 1.8 years later, when the FDA's table was read. source | |
| Nov 2024 | Approval | EU | EMA approval source | |
| 15 Nov 2024 | Revumenib Small-molecule menin inhibitor | Approval | US | Relapsed/refractory KMT2A-rearranged acute leukaemia, age ≥1: first menin inhibitor source |
| Nov 2024 | Withdrawal | US | Urothelial cancer indication voluntarily withdrawn after TROPiCS-04 source | |
| Nov 2024 | Approval | China | NMPA approval, pretreated advanced TNBC (OptiTROP-Breast01); first TROP2 ADC approved in China source | |
| 8 Nov 2024 | Obecabtagene autoleucel CAR-T (CD19, fast off-rate) | Approval | US | FELIX; approved without REMS source |
| 29 Oct 2024 | Accelerated approval | US | Treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 1.9 years later, when the FDA's table was read. source | |
| 18 Oct 2024 | Zolbetuximab Monoclonal antibody (anti-Claudin 18.2) | Approval | US | SPOTLIGHT/GLOW; companion diagnostic VENTANA CLDN18 (43-14A) |
| 15 Oct 2024 | Optune / Optune Pax (TTFields) Device (tumour treating fields) | Approval | US | Optune Lua, metastatic NSCLC after platinum (LUNAR) source |
| Oct 2024 | Filing / deal | US | Merck co-development of R-DXd under the Daiichi Sankyo alliance source | |
| 10 Oct 2024 | Inavolisib Small-molecule PI3Kα inhibitor and degrader | Approval | US | PIK3CA-mutant HR+/HER2- endocrine-resistant advanced breast cancer with palbociclib and fulvestrant (INAVO120) source |
| 27 Sept 2024 | Confirmed | US | Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy *Confirmed: the accelerated approval of 2020 converted to traditional approval 4.4 years after it was granted. | |
| 27 Sept 2024 | Confirmed | US | Formulation: Adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapyConfirmed: the accelerated approval of 2024 converted to traditional approval 0.5 years after it was granted. | |
| 25 Sept 2024 | Approval | US | Unresectable stage III after chemoradiation (LAURA) source | |
| 20 Sept 2024 | Approval | US | IMROZ frontline | |
| 19 Sept 2024 | Amivantamab Bispecific antibody (EGFR×MET) | Approval | US | After osimertinib, with chemotherapy (MARIPOSA-2) source |
| 17 Sept 2024 | Approval | US | Adjuvant stage II-III HR+/HER2- early breast cancer at high risk (NATALEE) source | |
| Sept 2024 | Cadonilimab Bispecific antibody (PD-1×CTLA-4) | Approval | China | First-line cervical cancer (COMPASSION-16) source |
| 12 Sept 2024 | Atezolizumab Monoclonal antibody (anti-PD-L1) | Approval | US | Subcutaneous atezolizumab (Tecentriq Hybreza) source |
| 19 Aug 2024 | Amivantamab Bispecific antibody (EGFR×MET) | Approval | US | First-line EGFR-mutant NSCLC with lazertinib (MARIPOSA) source |
| Aug 2024 | Designation | US | Breakthrough Therapy designation, extensive-stage SCLC after platinum source | |
| Aug 2024 | Odronextamab Bispecific T-cell engager (CD20×CD3) | Approval | EU | Conditional approval DLBCL and FL |
| Aug 2024 | Shield Blood-based colorectal cancer screening test | Approval | US | Medicare coverage under the blood-based CRC screening NCD source |
| 6 Aug 2024 | Approval | US | Grade 2 IDH-mutant astrocytoma or oligodendroglioma after surgery, age ≥12 (INDIGO): first targeted therapy for low-grade glioma source | |
| 2 Aug 2024 | Afamitresgene autoleucel TCR-T (MAGE-A4) | Accelerated approval | US | Treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 2.1 years later, when the FDA's table was read. source |
| 1 Aug 2024 | Afamitresgene autoleucel TCR-T (MAGE-A4) | Approval | US | Accelerated approval, MAGE-A4+ HLA-A*02+ advanced synovial sarcoma (SPEARHEAD-1): first TCR-T for a solid tumour source |
| 1 Aug 2024 | Dostarlimab Monoclonal antibody (anti-PD-1) | Approval | US | All-comer primary advanced/recurrent endometrial cancer with chemotherapy source |
| 30 Jul 2024 | Approval | US | Dara-VRd induction/consolidation (PERSEUS) | |
| 29 Jul 2024 | Shield Blood-based colorectal cancer screening test | Approval | US | PMA approval: first blood test for primary colorectal cancer screening (ECLIPSE) source |
| 15 Jul 2024 | Mobocertinib Small-molecule EGFR exon 20 insertion TKI (irreversible) | Withdrawal | US | Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapyWithdrawn: the indication came off the label 2.8 years after its accelerated approval. |
| 2024 | Brenetafusp ImmTAC (PRAME TCR × CD3 bispecific) | Designation | US | Phase 3 PRISM-MEL-301 initiated after FDA alignment on design |
| 2024 | Petosemtamab Bispecific antibody (EGFR × LGR5) | Designation | US | Breakthrough Therapy designation for HNSCC |
| 26 Jun 2024 | Complete response letter | US | Complete response letter citing third-party manufacturing inspection source | |
| 24 Jun 2024 | Accelerated approval | US | Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. source | |
| 21 Jun 2024 | Approval | US | KRAS G12C colorectal cancer with cetuximab (accelerated) source | |
| Jun 2024 | Actinium-225 PSMA agents Targeted alpha therapy | Filing / deal | US | AstraZeneca completes Fusion Pharmaceuticals acquisition; FPI-2265 phase 3 planned source |
| Jun 2024 | Designation | US | Breakthrough Therapy designation, previously treated metastatic PDAC source | |
| Jun 2024 | Letetresgene autoleucel TCR-T (NY-ESO-1) | Designation | US | Breakthrough Therapy for MRCLS |
| Jun 2024 | Lutetium-177 dotatate Radioligand therapy (beta) | Label change | US | First-line label based on NETTER-2 source |
| Jun 2024 | Designation | US | Breakthrough Therapy designation, ROS1+ NSCLC after prior ROS1 TKI source | |
| 14 Jun 2024 | Blinatumomab Bispecific T-cell engager (CD19×CD3) | Approval | US | Consolidation in CD19+ Ph-negative B-ALL regardless of MRD (E1910) source |
| 13 Jun 2024 | Repotrectinib Small-molecule kinase inhibitor (ROS1 / NTRK) | Accelerated approval | US | Treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic where surgical resection is likely results in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapyAccelerated approval on a surrogate endpoint; the confirmatory requirement was still open 2.3 years later, when the FDA's table was read. source |
| 12 Jun 2024 | Confirmed | US | Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) *Confirmed: the accelerated approval of 2020 converted to traditional approval 4.1 years after it was granted. source | |
| 12 Jun 2024 | Confirmed | US | Formulation: Adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)Confirmed: the accelerated approval of 2024 converted to traditional approval 0.2 years after it was granted. | |
| 1 Jun 2024 | Accelerated approval | US | In combination with cetuximab for the treatment of adult patients with KRAS G12C mutated locally advanced or metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.Accelerated approval on a surrogate endpoint, with a confirmatory trial required. source | |
| 29 May 2024 | Approval | US | Paediatric ≥2 years source | |
| 24 May 2024 | Ivonescimab Bispecific antibody (PD-1×VEGF) | Approval | China | EGFR-mutant NSCLC after TKI, with chemotherapy (HARMONi-A) source |
| 23 May 2024 | Shield Blood-based colorectal cancer screening test | Advisory committee | US | FDA advisory committee votes favourably source |
| 16 May 2024 | Infigratinib Oral FGFR1 to 3 kinase inhibitor | Withdrawal | US | Treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangement as detected by an FDA approved testWithdrawn: the indication came off the label 3.0 years after its accelerated approval. source |
| 16 May 2024 | Accelerated approval | US | Adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapyAccelerated approval, ES-SCLC after platinum (DeLLphi-301) source | |
| May 2024 | Camrelizumab Monoclonal antibody (anti-PD-1) | Complete response letter | US | Complete response letter for camrelizumab + rivoceranib in HCC (manufacturing/inspection) |
| May 2024 | Camrelizumab + rivoceranib PD-1 antibody + oral VEGFR2 inhibitor | Complete response letter | US | First CRL: manufacturing inspection findings |
| 15 May 2024 | Lisocabtagene maraleucel CAR-T (CD19, defined CD4:CD8) | Accelerated approval | US | Adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. source |
| 29 Apr 2024 | Confirmed | US | Treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapyFull approval with OS benefit (innovaTV 301) source | |
| 24 Apr 2024 | Alpelisib Small-molecule PI3Kα inhibitor | Accelerated approval | US | Formulation: Treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 2.4 years later, when the FDA's table was read. |
| 23 Apr 2024 | Lutetium-177 dotatate Radioligand therapy (beta) | Approval | US | Paediatric patients ≥12 years source |
| 23 Apr 2024 | Tovorafenib Small-molecule type II RAF inhibitor | Accelerated approval | US | Patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 2.4 years later, when the FDA's table was read. source |
| 18 Apr 2024 | Tisagenlecleucel CAR-T (CD19) | Label change | US | Class boxed warning for T-cell malignancies |
| 10 Apr 2024 | Accelerated approval | US | Formulation: Adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 10 Apr 2024 | Accelerated approval | US | Formulation: Adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)Accelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 10 Apr 2024 | Accelerated approval | US | Formulation: Adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment optionsAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 5 Apr 2024 | Ciltacabtagene autoleucel CAR-T (BCMA) | Approval | US | Relapsed myeloma after ≥1 prior line, lenalidomide-refractory (CARTITUDE-4) source |
| 5 Apr 2024 | Accelerated approval | US | Adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.HER2 IHC3+ solid tumours, tumour-agnostic (accelerated) The confirmatory requirement was still open 2.5 years later, when the FDA's table was read. source | |
| 25 Mar 2024 | Odronextamab Bispecific T-cell engager (CD20×CD3) | Complete response letter | US | CRLs for DLBCL and FL, confirmatory trial enrolment status |
| 22 Mar 2024 | Confirmed | US | Adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved testFull approval with OS benefit (MIRASOL) source | |
| 21 Mar 2024 | Lisocabtagene maraleucel CAR-T (CD19, defined CD4:CD8) | Accelerated approval | US | Adult patients with relapsed/ refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in patients who have received at least two prior lines of therapy including a Bruton’s tyrosine kinase (BTK) inhibitor and a B-cell lymphoma-2 (BCL-2) inhibitorAccelerated approval on a surrogate endpoint; the confirmatory requirement was still open 2.5 years later, when the FDA's table was read. |
| 19 Mar 2024 | Ponatinib Small-molecule kinase inhibitor (pan-BCR::ABL1 incl. T315I) | Accelerated approval | US | Adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.Frontline Ph+ ALL (PhALLCON), accelerated The confirmatory requirement was still open 2.5 years later, when the FDA's table was read. |
| 18 Mar 2024 | Copanlisib Intravenous pan-class I PI3K inhibitor (α/δ predominant) | Withdrawal | US | Treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapiesWithdrawn: the indication came off the label 6.5 years after its accelerated approval. |
| Mar 2024 | Approval | US | Second-line ESCC (RATIONALE-302) | |
| Mar 2024 | Zolbetuximab Monoclonal antibody (anti-Claudin 18.2) | Approval | Japan | World-first approval |
| Mar 2024 | Designation | US | Breakthrough Therapy designation source | |
| 14 Mar 2024 | Lisocabtagene maraleucel CAR-T (CD19, defined CD4:CD8) | Approval | US | First CAR-T in CLL (TRANSCEND CLL 004), accelerated |
| 7 Mar 2024 | Zanubrutinib Small-molecule covalent BTK inhibitor (second generation) | Accelerated approval | US | Adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapyAccelerated approval on a surrogate endpoint; the confirmatory requirement was still open 2.5 years later, when the FDA's table was read. source |
| 6 Mar 2024 | Label change | US | Paediatric expansion | |
| 1 Mar 2024 | Amivantamab Bispecific antibody (EGFR×MET) | Confirmed | US | Treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum based chemotherapyFirst-line exon 20 insertion with chemotherapy (PAPILLON) source |
| 26 Feb 2024 | Actinium-225 DOTATATE Targeted alpha therapy | Filing / deal | US | BMS completes RayzeBio acquisition ($4.1B) source |
| 23 Feb 2024 | Melphalan flufenamide Peptide-drug conjugate | Withdrawal | US | In combination with dexamethasone for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38 directed monoclonal antibodyWithdrawn: the indication came off the label 3.0 years after its accelerated approval. source |
| 20 Feb 2024 | Teclistamab Bispecific T-cell engager (BCMA×CD3) | Label change | US | Biweekly dosing added for responders source |
| 16 Feb 2024 | Lifileucel TIL cell therapy | Accelerated approval | US | Adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.Accelerated approval, unresectable/metastatic melanoma after anti-PD-1 (C-144-01): first TIL therapy The confirmatory requirement was still open 2.6 years later, when the FDA's table was read. source |
| 16 Feb 2024 | Approval | US | First-line with chemotherapy (FLAURA2) source | |
| 15 Feb 2024 | Tepotinib Small-molecule MET tyrosine kinase inhibitor | Confirmed | US | Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.Confirmed: the accelerated approval of 2021 converted to traditional approval 3.0 years after it was granted. |
| Feb 2024 | Vepdegestrant PROTAC oestrogen receptor degrader | Designation | US | Fast Track designation source |
| 25 Jan 2024 | Confirmed | US | Treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenibConfirmed: the accelerated approval of 2018 converted to traditional approval 5.2 years after it was granted. source | |
| 19 Jan 2024 | Axicabtagene ciloleucel CAR-T (CD19) | Label change | US | Class boxed warning for T-cell malignancies source |
| 19 Jan 2024 | Ciltacabtagene autoleucel CAR-T (BCMA) | Label change | US | Class boxed warning for T-cell malignancies source |
| 19 Jan 2024 | Erdafitinib Small-molecule kinase inhibitor (pan-FGFR) | Confirmed | US | Treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC), that has: susceptible FGFR3 or FGFR2 genetic alterations, and progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA.Confirmed: the accelerated approval of 2019 converted to traditional approval 4.8 years after it was granted. |
| Dec 2023 | Complete response letter | US | Complete response letter citing third-party manufacturing inspection findings | |
| 15 Dec 2023 | Confirmed | US | In combination with pembrolizumab for the treatment of adult patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapyFull approval with pembrolizumab, all first-line advanced urothelial cancer (EV-302) source | |
| Dec 2023 | Filing / deal | US | BLA submitted (HERTHENA-Lung01) source | |
| 15 Dec 2023 | Confirmed | US | In combination with enfortumab vedotin-ejfv for the treatment of adult patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapyConfirmed: the accelerated approval of 2023 converted to traditional approval 0.7 years after it was granted. source | |
| Dec 2023 | Sotorasib Small-molecule inhibitor (KRAS G12C) | Complete response letter | US | FDA declines full approval based on CodeBreaK 200; postmarketing dose study required source |
| 14 Dec 2023 | Approval | US | Advanced RCC after PD-1/PD-L1 and VEGF-TKI (LITESPARK-005) source | |
| 13 Dec 2023 | Eflornithine (DFMO) Small-molecule ornithine decarboxylase inhibitor | Approval | US | First oral maintenance therapy; externally controlled evidence source |
| 11 Dec 2023 | Izalontamab brengitecan Bispecific ADC | Filing / deal | US | BMS licenses global rights ex-China from SystImmune (up to $8.4B) source |
| 1 Dec 2023 | Pirtobrutinib Small-molecule non-covalent (reversible) BTK inhibitor | Accelerated approval | US | Adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitorCLL/SLL accelerated approval |
| 27 Nov 2023 | Approval | US | First systemic therapy for desmoid tumours (DeFi) source | |
| 16 Nov 2023 | Approval | US | HR+/HER2- breast cancer with PIK3CA/AKT1/PTEN alteration, with fulvestrant (CAPItello-291): first AKT inhibitor source | |
| Nov 2023 | Designation | US | Breakthrough Therapy designation, anti-PD-1-failed melanoma source | |
| 8 Nov 2023 | Fruquintinib Small-molecule kinase inhibitor (VEGFR1-3) | Approval | US | FRESCO-2 |
| 27 Oct 2023 | Approval | US | First FDA approval for nasopharyngeal carcinoma | |
| 20 Oct 2023 | Entrectinib Small-molecule TRK/ROS1/ALK TKI (CNS-penetrant) | Accelerated approval | US | Formulation: Adult and pediatric patients older than 1 month of age with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation as detected by an FDA-approved test, are metastatic or where surgical resection is likely to result in severe morbidity and have progressed following treatment or have no satisfactory alternative therapy .Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 2.9 years later, when the FDA's table was read. source |
| 16 Oct 2023 | Approval | US | Perioperative NSCLC (KEYNOTE-671) source | |
| 12 Oct 2023 | Confirmed | US | Treatment of adults and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC)Confirmed: the accelerated approval of 2018 converted to traditional approval 4.8 years after it was granted. source | |
| 11 Oct 2023 | Encorafenib Small-molecule kinase inhibitor (BRAF) | Approval | US | BRAF V600E NSCLC with binimetinib source |
| Sept 2023 | Approval | EU | EMA approval source | |
| 6 Sept 2023 | Confirmed | US | Treatment of adults and pediatrics patients 12 years and older with metastatic merkel cell carcinoma (MCC)Confirmed: the accelerated approval of 2017 converted to traditional approval 6.5 years after it was granted. | |
| Aug 2023 | Label change | US | With trifluridine/tipiracil in refractory mCRC | |
| Aug 2023 | Trifluridine/tipiracil Cytotoxic chemotherapy (oral nucleoside) | Approval | US | SUNLIGHT combination |
| 14 Aug 2023 | Elranatamab Bispecific T-cell engager (BCMA×CD3) | Accelerated approval | US | Adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 3.1 years later, when the FDA's table was read. source |
| 11 Aug 2023 | Niraparib Small-molecule PARP inhibitor | Approval | US | Niraparib + abiraterone (Akeega) for BRCA-mutated mCRPC (MAGNITUDE) source |
| 9 Aug 2023 | Pralsetinib Small-molecule kinase inhibitor (RET) | Confirmed | US | Treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved testConfirmed: the accelerated approval of 2020 converted to traditional approval 2.9 years after it was granted. |
| 9 Aug 2023 | Talquetamab Bispecific T-cell engager (GPRC5D×CD3) | Accelerated approval | US | Adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibodyAccelerated approval on a surrogate endpoint; the confirmatory requirement was still open 3.1 years later, when the FDA's table was read. source |
| 31 Jul 2023 | Dostarlimab Monoclonal antibody (anti-PD-1) | Approval | US | dMMR primary advanced/recurrent endometrial cancer with chemotherapy (RUBY) source |
| 20 Jul 2023 | Pralsetinib Small-molecule kinase inhibitor (RET) | Withdrawal | US | Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapyWithdrawn: the indication came off the label 2.6 years after its accelerated approval. |
| 20 Jul 2023 | Quizartinib Small-molecule kinase inhibitor (FLT3-ITD, type II) | Approval | US | Frontline FLT3-ITD AML (QuANTUM-First) |
| Jul 2023 | Approval | EU | Conditional marketing authorisation source | |
| 2023 | Talicabtagene autoleucel CAR-T (CD19, humanised) | Approval | IN | CDSCO/DCGI market authorisation; the developer's page gives the year only source |
| 20 Jun 2023 | Blinatumomab Bispecific T-cell engager (CD19×CD3) | Confirmed | US | Treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children 1Confirmed: the accelerated approval of 2018 converted to traditional approval 5.2 years after it was granted. source |
| 20 Jun 2023 | Talazoparib Small-molecule PARP inhibitor | Approval | US | HRR-mutant mCRPC with enzalutamide (TALAPRO-2) source |
| 15 Jun 2023 | Accelerated approval | US | Relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after two or more lines of systemic therapyAccelerated approval, relapsed/refractory DLBCL after ≥2 lines The confirmatory requirement was still open 3.3 years later, when the FDA's table was read. source | |
| 31 May 2023 | Olaparib Small-molecule PARP inhibitor | Approval | US | With abiraterone in BRCA-mutated mCRPC (PROpel) source |
| 19 May 2023 | Accelerated approval | US | Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.Accelerated approval in DLBCL (EPCORE NHL-1) The confirmatory requirement was still open 3.3 years later, when the FDA's table was read. | |
| 18 May 2023 | Withdrawal | US | Adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapyWithdrawn: the indication came off the label 9.5 years after its accelerated approval. | |
| 18 May 2023 | Withdrawal | US | Adult patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapyWithdrawn: the indication came off the label 6.3 years after its accelerated approval. | |
| May 2023 | Lifileucel TIL cell therapy | Filing / deal | US | BLA submitted source |
| 28 Apr 2023 | Confirmed | US | Patients with metastatic basal cell carcinoma (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriateConfirmed: the accelerated approval of 2021 converted to traditional approval 2.2 years after it was granted. | |
| 19 Apr 2023 | Confirmed | US | In combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies.Frontline Pola-R-CHP (POLARIX) | |
| Apr 2023 | Intismeran autogene Personalised mRNA neoantigen vaccine | Designation | EU | PRIME designation source |
| 6 Apr 2023 | Withdrawal | US | MCL and MZL indications voluntarily withdrawn after confirmatory trials missed | |
| 3 Apr 2023 | Accelerated approval | US | In combination with pembrolizumab for the treatment of adult patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapyAccelerated approval with pembrolizumab, cisplatin-ineligible first line source | |
| 3 Apr 2023 | Accelerated approval | US | In combination with enfortumab vedotin-ejfv for the treatment of adult patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. source | |
| 28 Mar 2023 | Confirmed | US | Treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or metastatic MSI-H or dMMR colorectal cancer that have progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecanConfirmed: the accelerated approval of 2017 converted to traditional approval 5.8 years after it was granted. | |
| 22 Mar 2023 | Retifanlimab Anti-PD-1 monoclonal antibody (IgG4) | Accelerated approval | US | Adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC)Accelerated approval on a surrogate endpoint, with a confirmatory trial required. source |
| Mar 2023 | Designation | US | Breakthrough Therapy designation source | |
| 3 Mar 2023 | Label change | US | Adjuvant indication broadened to remove Ki-67 requirement source | |
| 22 Feb 2023 | Intismeran autogene Personalised mRNA neoantigen vaccine | Designation | US | Breakthrough Therapy designation, adjuvant melanoma source |
| Feb 2023 | Filing / deal | US | AstraZeneca licenses global rights from KYM Biosciences source | |
| 9 Feb 2023 | Dostarlimab Monoclonal antibody (anti-PD-1) | Confirmed | US | Adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer (EC), as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen.Confirmed: the accelerated approval of 2021 converted to traditional approval 1.8 years after it was granted. |
| 6 Feb 2023 | Withdrawal | US | Adults patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agentWithdrawn: the indication came off the label 2.5 years after its accelerated approval. source | |
| 3 Feb 2023 | Approval | US | HR+/HER2- metastatic breast cancer after endocrine therapy and ≥2 chemotherapies (TROPiCS-02) source | |
| 27 Jan 2023 | Approval | US | ESR1-mutated ER+/HER2- advanced breast cancer after ≥1 endocrine therapy (EMERALD): first oral SERD source | |
| 27 Jan 2023 | Pirtobrutinib Small-molecule non-covalent (reversible) BTK inhibitor | Accelerated approval | US | Adult patients with relapsed or refractory mantle cel lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 3.6 years later, when the FDA's table was read. source |
| 19 Jan 2023 | Tucatinib Small-molecule kinase inhibitor (HER2) | Accelerated approval | US | In combination with trastuzumab for the treatment of adult patients with RAS wild-type, HER2-positive, unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapyHER2+ RAS wild-type metastatic colorectal cancer with trastuzumab (MOUNTAINEER, accelerated) The confirmatory requirement was still open 3.7 years later, when the FDA's table was read. source |
| 19 Jan 2023 | Zanubrutinib Small-molecule covalent BTK inhibitor (second generation) | Approval | US | CLL/SLL source |
| Jan 2023 | FAP-2286 (177Lu / 68Ga) Theranostic pair (peptide radioligand) | Filing / deal | US | Novartis acquires rights after Clovis bankruptcy source |
| Jan 2023 | Designation | US | Breakthrough Therapy designation, HER2+ biliary tract cancer source | |
| 22 Dec 2022 | Accelerated approval | US | Adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 3.7 years later, when the FDA's table was read. | |
| 16 Dec 2022 | Confirmed | US | Dosing Regimen: Alternative dose/schedule of 400mg every 6 weeks for adult patients with melanoma, hepatocellular carcinoma, Merkel cell carcinoma, gastric cancer, non-small cell lung cancer, renal cell carcinoma, endometrial carcinoma, cervical carcinoma, urothelial carcinoma, head and neck squamous cell carcinoma, small cell lung cancer, esophageal cancer, microsatellite instability-high or mismatch repair deficient solid tumorsConfirmed: the accelerated approval of 2020 converted to traditional approval 2.6 years after it was granted. | |
| 16 Dec 2022 | Confirmed | US | Dosing Regimen: Alternate Dose/Schedule of 400 mg every 6 weeks for adult patients with unresectable or metastatic tumor mutational burden high [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment optionsConfirmed: the accelerated approval of 2020 converted to traditional approval 2.5 years after it was granted. | |
| 16 Dec 2022 | Confirmed | US | Dosing Regimen: Alternative dose/schedule of 400mg every 6 weeks for adult patients with cutaneous squamous cell carcinomaConfirmed: the accelerated approval of 2020 converted to traditional approval 2.5 years after it was granted. | |
| Dec 2022 | Approval | EU | Conditional marketing authorisation source | |
| Dec 2022 | Approval | EU | EMA approval source | |
| Dec 2022 | Nonavalent HPV vaccine Prophylactic vaccine (virus-like particles) | Label change | WHO | One-dose schedule endorsed (SAGE) |
| Dec 2022 | Revumenib Small-molecule menin inhibitor | Designation | US | Breakthrough Therapy designation source |
| 12 Dec 2022 | Accelerated approval | US | Adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.Accelerated approval, KRAS G12C NSCLC after ≥1 therapy The confirmatory requirement was still open 3.8 years later, when the FDA's table was read. source | |
| 11 Dec 2022 | Rucaparib Small-molecule PARP inhibitor | Withdrawal | US | Clovis Oncology bankruptcy; asset sold to pharma& |
| 2 Dec 2022 | Atezolizumab Monoclonal antibody (anti-PD-L1) | Withdrawal | US | Patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 as determined by an FDA approved test or who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 statusWithdrawn: the indication came off the label 5.6 years after its accelerated approval. |
| 1 Dec 2022 | Olutasidenib Small-molecule IDH1 inhibitor | Approval | US | Study 2102-HEM-101 pivotal cohort |
| 22 Nov 2022 | Withdrawal | US | Withdrawn after DREAMM-3 failed to confirm benefit source | |
| Nov 2022 | Niraparib Small-molecule PARP inhibitor | Label change | US | Second-line maintenance restricted to gBRCA after OS data source |
| Nov 2022 | Designation | US | Breakthrough Therapy designation, ES-SCLC after platinum source | |
| 14 Nov 2022 | Accelerated approval | US | Adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved testAccelerated approval, FRα-high platinum-resistant ovarian cancer (SORAYA) source | |
| 10 Nov 2022 | Approval | US | Paediatric high-risk Hodgkin lymphoma source | |
| 25 Oct 2022 | Teclistamab Bispecific T-cell engager (BCMA×CD3) | Accelerated approval | US | Adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibodyAccelerated approval, relapsed/refractory myeloma after ≥4 lines (MajesTEC-1) source |
| 21 Oct 2022 | Approval | US | HCC with tremelimumab (HIMALAYA) source | |
| 12 Oct 2022 | Confirmed | US | Adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with 2 or more tyrosine kinase inhibitors (TKIs)Confirmed: the accelerated approval of 2021 converted to traditional approval 1.0 year after it was granted. | |
| 30 Sept 2022 | Futibatinib Small-molecule irreversible kinase inhibitor (FGFR1-4) | Accelerated approval | US | Adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangementsAccelerated approval on a surrogate endpoint; the confirmatory requirement was still open 4.0 years later, when the FDA's table was read. |
| 21 Sept 2022 | Accelerated approval | US | Adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options *RET-fusion solid tumours (tumour-agnostic, accelerated); full approval in NSCLC source | |
| 21 Sept 2022 | Confirmed | US | Adult patients with metastatic RET fusion-positive Non-Small Cell Lung Cancer (NSCLC)Confirmed: the accelerated approval of 2020 converted to traditional approval 2.4 years after it was granted. | |
| Sept 2022 | Approval | EU | EMA approval, PD-L1 <1% melanoma source | |
| 2 Sept 2022 | Approval | US | Biliary tract cancer with chemotherapy (TOPAZ-1) source | |
| 24 Aug 2022 | Teclistamab Bispecific T-cell engager (BCMA×CD3) | Approval | EU | Conditional approval: first BCMA bispecific worldwide source |
| 11 Aug 2022 | Accelerated approval | US | Adult patients with unresectable or metastatic NSCLC whose tumors have an activating HER2 (ERBB2) mutation, as detected by an FDA-approved test, and who have received a prior systemic therapyHER2-mutant NSCLC (accelerated) The confirmatory requirement was still open 4.1 years later, when the FDA's table was read. source | |
| 10 Aug 2022 | Capmatinib Small-molecule MET tyrosine kinase inhibitor | Confirmed | US | Adult patients with mNSCLC whose tumors have a mutation that leads to MET exon 14 skipping as detected by an FDA-approved testConfirmed: the accelerated approval of 2020 converted to traditional approval 2.3 years after it was granted. |
| 5 Aug 2022 | Approval | US | HER2-low metastatic breast cancer (DESTINY-Breast04); first HER2-low indication source | |
| 3 Aug 2022 | Acalabrutinib Small-molecule covalent BTK inhibitor (second generation) | Label change | US | Tablet formulation co-administrable with acid-reducing agents |
| 18 Jul 2022 | Clofarabine Purine nucleoside analogue (antimetabolite) | Confirmed | US | Treatment of pediatric patients 1 to 21 yrs old with relapsed or refractory acute lymphocytic leukemia (ALL) after at least 2 prior regimensConfirmed: the accelerated approval of 2004 converted to traditional approval 17.6 years after it was granted. |
| 29 Jun 2022 | Cadonilimab Bispecific antibody (PD-1×CTLA-4) | Approval | China | First PD-1×CTLA-4 bispecific approved anywhere |
| 22 Jun 2022 | Dabrafenib Small-molecule BRAF kinase inhibitor | Accelerated approval | US | In combination with trametinib for adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. *Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 4.2 years later, when the FDA's table was read. source |
| 22 Jun 2022 | Trametinib Small-molecule allosteric MEK1/2 inhibitor | Accelerated approval | US | In combination with dabrafenib for adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options *Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 4.2 years later, when the FDA's table was read. source |
| Jun 2022 | Rucaparib Small-molecule PARP inhibitor | Label change | US | Later-line treatment indication withdrawn after ARIEL4 OS imbalance |
| 31 May 2022 | Umbralisib Oral PI3Kδ / CK1ε inhibitor | Withdrawal | US | Adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20- based regimenWithdrawn: the indication came off the label 1.3 years after its accelerated approval. |
| 31 May 2022 | Umbralisib Oral PI3Kδ / CK1ε inhibitor | Withdrawal | US | Adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapyWithdrawn: the indication came off the label 1.3 years after its accelerated approval. |
| 27 May 2022 | Tisagenlecleucel CAR-T (CD19) | Accelerated approval | US | Treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapyAccelerated approval on a surrogate endpoint; the confirmatory requirement was still open 4.3 years later, when the FDA's table was read. |
| 25 May 2022 | Ivosidenib Small-molecule IDH1 inhibitor | Approval | US | Combination with azacitidine (AGILE) |
| May 2022 | Ripretinib Small-molecule kinase inhibitor (KIT/PDGFRA switch-control) | Label change | US | Label updated with INTRIGUE data |
| May 2022 | Filing / deal | China | Merck licenses ex-Greater-China rights (deal expanded December 2022) source | |
| 4 May 2022 | Confirmed | US | Adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic settingSecond-line HER2+ metastatic breast cancer (DESTINY-Breast03) source | |
| 2 May 2022 | Vincristine Vinca alkaloid (microtubule inhibitor) | Withdrawal | US | Adults with Philadelphia (PH) chromosome negative (-) ALL in second relapse or greater relapsed or whose disease has progressed following 2 or greater treatment lines of anti-leukemia therapiesWithdrawn: the indication came off the label 9.7 years after its accelerated approval. |
| Apr 2022 | Approval | US | First nab-paclitaxel generics source | |
| Apr 2022 | Tebentafusp ImmTAC (TCR×CD3 bispecific) | Approval | EU | EMA approval source |
| 5 Apr 2022 | Alpelisib Small-molecule PI3Kα inhibitor | Accelerated approval | US | Treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapyAccelerated approval on a surrogate endpoint; the confirmatory requirement was still open 4.5 years later, when the FDA's table was read. |
| 1 Apr 2022 | Axicabtagene ciloleucel CAR-T (CD19) | Approval | US | Second-line LBCL refractory or relapsed within 12 months (ZUMA-7) source |
| 24 Mar 2022 | Panobinostat Pan-HDAC inhibitor | Withdrawal | US | In combination with bortezomib (BTZ) and dexamethasone (DEX) for the treatment of patients with multiple myeloma (MM) who have received at least 2 prior regimens, including BTZ and an immunomodulatory agent.Withdrawn: the indication came off the label 7.1 years after its accelerated approval. |
| 23 Mar 2022 | Approval | US | PSMA+ mCRPC after ARPI and taxane (VISION) source | |
| 18 Mar 2022 | Approval | US | Unresectable or metastatic melanoma, age ≥12 (RELATIVITY-047): first LAG-3 therapy source | |
| Mar 2022 | Label change | US | First generics launch (volume-limited) | |
| Mar 2022 | Sintilimab Monoclonal antibody (anti-PD-1, IgG4) | Complete response letter | US | Complete response letter for ORIENT-11 (first-line non-squamous NSCLC); ODAC voted 14 to 1 that additional data were needed for US applicability source |
| 11 Mar 2022 | Olaparib Small-molecule PARP inhibitor | Approval | US | Adjuvant gBRCA high-risk HER2-negative early breast cancer (OlympiA) source |
| 4 Mar 2022 | Approval | US | Neoadjuvant NSCLC with chemotherapy (CheckMate 816) source | |
| 28 Feb 2022 | Ciltacabtagene autoleucel CAR-T (BCMA) | Approval | US | Relapsed/refractory myeloma after ≥4 lines (CARTITUDE-1) source |
| 18 Feb 2022 | Idelalisib Small-molecule PI3Kδ inhibitor | Withdrawal | US | For the treatment of relapsed follicular B-cell Non-Hodgkin Lymphoma (FL) in patients who have received at least 2 prior systemic therapies and relapsed small lymphocytic lymphoma (SLL) in patients who have received at least 2 prior systemic therapiesWithdrawn: the indication came off the label 7.6 years after its accelerated approval. |
| 4 Feb 2022 | Withdrawal | US | For patients with recurrent or locally advanced or metastatic gastric or GEJ adenocarcinoma whose tumors express PD-L1 [CPS ≥1] as determined by an FDA-approved test, with disease progression on/after two or more prior lines of therapy including fluoropyrimidine and platinum containing chemotherapy and if appropriate, HER2/NEU targeted therapyWithdrawn: the indication came off the label 4.4 years after its accelerated approval. | |
| 25 Jan 2022 | Tebentafusp ImmTAC (TCR×CD3 bispecific) | Approval | US | HLA-A*02:01+ unresectable or metastatic uveal melanoma: first TCR therapeutic approved source |
| Jan 2022 | Satricabtagene autoleucel CAR-T (Claudin 18.2) | Designation | US | RMAT designation, CLDN18.2+ gastric cancer source |
| Jan 2022 | Designation | US | Breakthrough Therapy designation, c-MET overexpressing NSCLC source | |
| 31 Dec 2021 | Approval | China | HER2-expressing urothelial cancer after platinum source | |
| 23 Dec 2021 | Designation | US | Breakthrough Therapy designation, EGFR-mutant NSCLC after TKI and platinum source | |
| 17 Dec 2021 | Duvelisib Small-molecule PI3Kδ/γ inhibitor | Withdrawal | US | Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least 2 prior systemic therapiesWithdrawn: the indication came off the label 3.2 years after its accelerated approval. |
| 8 Dec 2021 | Withdrawal | US | Formulation: Treatment of peripheral T-cell lymphoma in adults who have received at least one prior therapyWithdrawn: the indication came off the label 1.7 years after its accelerated approval. | |
| 22 Nov 2021 | Approval | EU | EMA approval, pretreated metastatic TNBC source | |
| 29 Oct 2021 | Accelerated approval | US | Adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with 2 or more tyrosine kinase inhibitors (TKIs)Accelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 15 Oct 2021 | Atezolizumab Monoclonal antibody (anti-PD-L1) | Approval | US | Adjuvant NSCLC, PD-L1 ≥1% (IMpower010) source |
| Oct 2021 | Signatera Tumour-informed ctDNA MRD test | Approval | US | Medicare coverage for immunotherapy response monitoring, pan-cancer source |
| 13 Oct 2021 | Confirmed | US | Treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS >/=1) as determined by an FDA approved testConfirmed: the accelerated approval of 2018 converted to traditional approval 3.3 years after it was granted. | |
| 12 Oct 2021 | Approval | US | Adjuvant high-risk node-positive HR+/HER2- early breast cancer, Ki-67 ≥20% (monarchE) source | |
| 6 Oct 2021 | Atezolizumab Monoclonal antibody (anti-PD-L1) | Withdrawal | US | In combination with paclitaxel protein-bound for unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells of any intensity covering = 1% of the tumor area), as determined by an FDA-approved test.Withdrawn: the indication came off the label 2.6 years after its accelerated approval. source |
| 20 Sept 2021 | Accelerated approval | US | Treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapyAccelerated approval, recurrent or metastatic cervical cancer after chemotherapy (innovaTV 204) source | |
| 15 Sept 2021 | Mobocertinib Small-molecule EGFR exon 20 insertion TKI (irreversible) | Accelerated approval | US | Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 14 Sept 2021 | Zanubrutinib Small-molecule covalent BTK inhibitor (second generation) | Accelerated approval | US | Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimenAccelerated approval on a surrogate endpoint; the confirmatory requirement was still open 5.0 years later, when the FDA's table was read. |
| 31 Aug 2021 | Confirmed | US | Locally advanced or metastatic urothelial carcinoma ineligible for cisplatin-containing chemotherapy 1Confirmed: the accelerated approval of 2017 converted to traditional approval 4.3 years after it was granted. source | |
| 27 Aug 2021 | Atezolizumab Monoclonal antibody (anti-PD-L1) | Withdrawal | US | TNBC indication withdrawn after IMpassion131 source |
| 19 Aug 2021 | Confirmed | US | Locally advanced or metastatic urothelial carcinoma that: • progressed during or following platinum-containing chemotherapy • progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapyConfirmed: the accelerated approval of 2017 converted to traditional approval 4.5 years after it was granted. | |
| 17 Aug 2021 | Dostarlimab Monoclonal antibody (anti-PD-1) | Accelerated approval | US | Treatment for adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment optionsdMMR solid tumours (tumour-agnostic, accelerated) The confirmatory requirement was still open 5.1 years later, when the FDA's table was read. source |
| Aug 2021 | Atezolizumab Monoclonal antibody (anti-PD-L1) | Withdrawal | US | Genentech withdrew the US TNBC indication after the confirmatory IMpassion131 trial (paclitaxel partner) showed no progression-free or overall survival benefit and the FDA's accelerated-approval review; the current Tecentriq label carries no breast cancer indication source |
| 13 Aug 2021 | Approval | US | VHL disease-associated RCC, CNS haemangioblastoma, pNET: first HIF-2α inhibitor source | |
| 30 Jul 2021 | Withdrawal | US | Peripheral T-cell lymphoma in patients who have received at least one prior therapyWithdrawn: the indication came off the label 10.1 years after its accelerated approval. | |
| 26 Jul 2021 | Confirmed | US | In combination with chemotherapy for locally recurrent unresectable or metastatic TNBC expressing PD L1 [CPS =10] as determined by an FDA-approved testHigh-risk early TNBC, neoadjuvant and adjuvant (KEYNOTE-522) source | |
| 23 Jul 2021 | Withdrawal | US | Hepatocellular carcinoma previously treated with sorafenibWithdrawn: the indication came off the label 3.8 years after its accelerated approval. | |
| 21 Jul 2021 | Confirmed | US | In combination with pembrolizumab for advanced endometrial carcinoma not MSI-H or dMMR, with progression following systemic therapy and not candidates for curative surgery or radiationFull approval, pMMR endometrial cancer (KEYNOTE-775) | |
| 21 Jul 2021 | Confirmed | US | In combination with lenvatinib for advanced endometrial carcinoma not MSI-H or dMMR, with progression following systemic therapy and not candidates for curative surgery or radiationConfirmed: the accelerated approval of 2019 converted to traditional approval 1.8 years after it was granted. | |
| 9 Jul 2021 | Confirmed | US | Adults with locally advanced or metastatic urothelial cancer who received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant, locally advanced, or metastatic settingFull approval and cisplatin-ineligible expansion (EV-301) source | |
| Jun 2021 | Designation | US | Breakthrough Therapy designation source | |
| Jun 2021 | Approval | China | Conditional approval, HER2+ gastric cancer after ≥2 lines source | |
| Jun 2021 | Galleri Multi-cancer early detection blood test | Filing / deal | US | Launched as a laboratory-developed test source |
| Jun 2021 | Designation | US | Breakthrough Therapy designation source | |
| Jun 2021 | Teclistamab Bispecific T-cell engager (BCMA×CD3) | Designation | US | Breakthrough Therapy designation source |
| 28 May 2021 | Infigratinib Oral FGFR1 to 3 kinase inhibitor | Accelerated approval | US | Treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangement as detected by an FDA approved testAccelerated approval on a surrogate endpoint, with a confirmatory trial required. source |
| 28 May 2021 | Sotorasib Small-molecule inhibitor (KRAS G12C) | Accelerated approval | US | Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.Accelerated approval, KRAS G12C NSCLC after ≥1 therapy: first KRAS inhibitor The confirmatory requirement was still open 5.3 years later, when the FDA's table was read. source |
| 26 May 2021 | Piflufolastat F-18 / Pylarify TruVu PET imaging agent | Approval | US | PSMA PET imaging in prostate cancer: first 18F PSMA agent source |
| 21 May 2021 | Amivantamab Bispecific antibody (EGFR×MET) | Accelerated approval | US | Treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum based chemotherapyAccelerated approval, EGFR exon 20 insertion NSCLC after platinum source |
| 14 May 2021 | Confirmed | US | Adults with newly diagnosed chronic phase Philadelphia chromosome positive CMLConfirmed: the accelerated approval of 2017 converted to traditional approval 3.4 years after it was granted. | |
| 5 May 2021 | Accelerated approval | US | In combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma 1Accelerated approval on a surrogate endpoint, with a confirmatory trial required. source | |
| 23 Apr 2021 | Accelerated approval | US | Treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma.Accelerated approval, relapsed/refractory DLBCL after ≥2 lines (LOTIS-2) The confirmatory requirement was still open 5.4 years later, when the FDA's table was read. source | |
| 22 Apr 2021 | Dostarlimab Monoclonal antibody (anti-PD-1) | Accelerated approval | US | Adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer (EC), as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen.Accelerated approval, dMMR recurrent/advanced endometrial cancer after platinum source |
| 13 Apr 2021 | Atezolizumab Monoclonal antibody (anti-PD-L1) | Withdrawal | US | Locally advanced or metastatic urothelial carcinoma that progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapyWithdrawn: the indication came off the label 4.9 years after its accelerated approval. |
| 13 Apr 2021 | Accelerated approval | US | Treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitorAccelerated approval on a surrogate endpoint, with a confirmatory trial required. source | |
| 7 Apr 2021 | Confirmed | US | Adults with metastatic TNBC following at least 2 prior therapies for metastatic diseaseFull approval in metastatic TNBC (ASCENT); accelerated approval in urothelial cancer source | |
| 30 Mar 2021 | CPX-351 (liposomal daunorubicin-cytarabine) Liposomal cytotoxic formulation | Label change | US | Paediatric expansion |
| 30 Mar 2021 | Withdrawal | US | Metastatic SCLC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapyWithdrawn: the indication came off the label 1.8 years after its accelerated approval. | |
| 5 Mar 2021 | Axicabtagene ciloleucel CAR-T (CD19) | Accelerated approval | US | Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapyRelapsed/refractory follicular lymphoma (ZUMA-5) The confirmatory requirement was still open 5.5 years later, when the FDA's table was read. source |
| 3 Mar 2021 | Lorlatinib Small-molecule kinase inhibitor (ALK/ROS1) | Confirmed | US | ALK-positive metastatic NSCLC that has progressed on: • Crizotinib and at least one other ALK inhibitor for metastatic disease; or • Alectinib as the first ALK inhibitor therapy for metastatic disease; or • Ceritinib as the first ALK inhibitor therapy for metastatic diseaseFirst-line ALK+ NSCLC (CROWN); full approval source |
| 26 Feb 2021 | Melphalan flufenamide Peptide-drug conjugate | Accelerated approval | US | In combination with dexamethasone for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38 directed monoclonal antibodyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. source |
| 22 Feb 2021 | Approval | US | First-line PD-L1 ≥50% NSCLC (EMPOWER-Lung 1) source | |
| 19 Feb 2021 | Withdrawal | US | Locally advanced or metastatic urothelial carcinoma that progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapyWithdrawn: the indication came off the label 3.8 years after its accelerated approval. | |
| Feb 2021 | Tebentafusp ImmTAC (TCR×CD3 bispecific) | Designation | US | Breakthrough Therapy designation source |
| 9 Feb 2021 | Accelerated approval | US | Patients with metastatic basal cell carcinoma (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriateAdvanced basal cell carcinoma after hedgehog inhibitor source | |
| 5 Feb 2021 | Umbralisib Oral PI3Kδ / CK1ε inhibitor | Accelerated approval | US | Adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20- based regimenAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 5 Feb 2021 | Umbralisib Oral PI3Kδ / CK1ε inhibitor | Accelerated approval | US | Adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 3 Feb 2021 | Tepotinib Small-molecule MET tyrosine kinase inhibitor | Accelerated approval | US | Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.Accelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 15 Jan 2021 | Accelerated approval | US | Treatment of patients with light chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide and dexamethasone in newly diagnosed patientsAccelerated approval on a surrogate endpoint, with a confirmatory trial required. source | |
| 15 Jan 2021 | Approval | US | HER2+ gastric/GEJ adenocarcinoma (DESTINY-Gastric01) source | |
| 29 Dec 2020 | Withdrawal | US | Metastatic SCLC with progression after platinum-based chemotherapy and at least one other line of therapyWithdrawn: the indication came off the label 2.4 years after its accelerated approval. | |
| 18 Dec 2020 | Approval | US | Adjuvant EGFR-mutant NSCLC after resection (ADAURA) source | |
| 18 Dec 2020 | Selinexor Small-molecule XPO1 (nuclear export) inhibitor | Confirmed | US | In combination with dexamethasone for adults with relapsed/refractory multiple myeloma after at least 4 prior therapies and refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti-CD38 monoclonal antibodyConfirmed: the accelerated approval of 2019 converted to traditional approval 1.5 years after it was granted. |
| Dec 2020 | Oncotype DX Gene-expression prognostic/predictive assay | Label change | US | RxPONDER extends to 1-3 positive nodes (postmenopausal) source |
| Dec 2020 | Sotorasib Small-molecule inhibitor (KRAS G12C) | Designation | US | Breakthrough Therapy designation source |
| 1 Dec 2020 | Pralsetinib Small-molecule kinase inhibitor (RET) | Accelerated approval | US | Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 1 Dec 2020 | Pralsetinib Small-molecule kinase inhibitor (RET) | Accelerated approval | US | Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 5.8 years later, when the FDA's table was read. |
| 25 Nov 2020 | Naxitamab Monoclonal antibody (anti-GD2, humanised) | Accelerated approval | US | In combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.Accelerated approval (Study 201, 12-230) The confirmatory requirement was still open 5.8 years later, when the FDA's table was read. |
| 13 Nov 2020 | Accelerated approval | US | In combination with chemotherapy for locally recurrent unresectable or metastatic TNBC expressing PD L1 [CPS =10] as determined by an FDA-approved testMetastatic TNBC, PD-L1 CPS ≥10, with chemotherapy (KEYNOTE-355) source | |
| 16 Oct 2020 | Approval | US | Venetoclax + azacitidine full approval in unfit AML (VIALE-A) | |
| 16 Oct 2020 | Venetoclax Small-molecule BCL-2 inhibitor | Confirmed | US | In combination with azacitidine or decitabine or low-dose cytarabine for newly-diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapyFull approval in AML (VIALE-A) source |
| 14 Oct 2020 | Confirmed | US | Adult and pediatric patients with refractory classical Hodgkin Lymphoma or who have relapsed after 3 or more prior lines of therapyConfirmed: the accelerated approval of 2017 converted to traditional approval 3.6 years after it was granted. | |
| 14 Oct 2020 | Confirmed | US | Adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma, or who have relapsed after 2 or more prior lines of therapyConfirmed: the accelerated approval of 2018 converted to traditional approval 2.3 years after it was granted. | |
| 2 Oct 2020 | Approval | US | With nivolumab in mesothelioma (CheckMate 743) source | |
| 25 Sept 2020 | Cetuximab sarotalocan Photoimmunotherapy conjugate (anti-EGFR antibody-IR700 dye) | Approval | Japan | World-first approval of a photoimmunotherapy drug |
| Sept 2020 | Designation | US | Breakthrough Therapy designation, HER2+ urothelial cancer source | |
| 4 Sept 2020 | Pralsetinib Small-molecule kinase inhibitor (RET) | Accelerated approval | US | Treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved testAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 1 Sept 2020 | Approval | US | Onureg maintenance in AML | |
| 26 Aug 2020 | FoundationOne CDx / Liquid CDx Comprehensive genomic profiling test | Approval | US | FoundationOne Liquid CDx approved source |
| 5 Aug 2020 | Accelerated approval | US | Adults patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agentAccelerated approval, relapsed/refractory myeloma after ≥4 lines (DREAMM-2) source | |
| 31 Jul 2020 | Tafasitamab Monoclonal antibody (anti-CD19, Fc-enhanced) | Accelerated approval | US | In combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).L-MIND accelerated approval The confirmatory requirement was still open 6.1 years later, when the FDA's table was read. |
| 24 Jul 2020 | Brexucabtagene autoleucel Autologous CD19 CAR-T (CD28 costimulatory domain) | Accelerated approval | US | Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).Accelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 7 Jul 2020 | Decitabine + cedazuridine (oral) Oral hypomethylating agent | Approval | US | MDS/CMML |
| 30 Jun 2020 | Confirmed | US | Locally advanced or metastatic urothelial carcinoma following diease progression on platinum-containing chemotherapy or disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapyConfirmed: the accelerated approval of 2017 converted to traditional approval 3.1 years after it was granted. | |
| 29 Jun 2020 | Approval | US | Phesgo SC | |
| 29 Jun 2020 | Approval | US | Phesgo (pertuzumab, trastuzumab, hyaluronidase) subcutaneous source | |
| 24 Jun 2020 | Accelerated approval | US | Dosing Regimen: Alternative dose/schedule of 400mg every 6 weeks for adult patients with cutaneous squamous cell carcinomaAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 22 Jun 2020 | Selinexor Small-molecule XPO1 (nuclear export) inhibitor | Accelerated approval | US | Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma (FL), after at least 2 lines of systemic therapy.Accelerated approval on a surrogate endpoint, with a confirmatory trial required. source |
| 18 Jun 2020 | Tazemetostat Small-molecule EZH2 inhibitor | Accelerated approval | US | Treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies. Treatment of adult patients with R/R FL who have no satisfactory alternative treatment optionsAccelerated approval, follicular lymphoma |
| 16 Jun 2020 | Accelerated approval | US | Treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden high (TMB H) [=10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options .TMB-high solid tumours (tumour-agnostic) The confirmatory requirement was still open 6.3 years later, when the FDA's table was read. source | |
| 16 Jun 2020 | Accelerated approval | US | Dosing Regimen: Alternate Dose/Schedule of 400 mg every 6 weeks for adult patients with unresectable or metastatic tumor mutational burden high [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment optionsAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| Jun 2020 | FoundationOne CDx / Liquid CDx Comprehensive genomic profiling test | Label change | US | TMB ≥10 mut/Mb companion claim for pembrolizumab source |
| 15 Jun 2020 | Lurbinectedin Cytotoxic (transcription inhibitor) | Accelerated approval | US | Treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after prior platinum-based chemotherapy .Accelerated approval, second-line SCLC The confirmatory requirement was still open 6.3 years later, when the FDA's table was read. |
| 29 May 2020 | Atezolizumab Monoclonal antibody (anti-PD-L1) | Approval | US | Unresectable HCC with bevacizumab (IMbrave150) source |
| 22 May 2020 | Brigatinib Small-molecule ALK/EGFR TKI (second generation) | Confirmed | US | Patients with ALK-positive metastatic NSCLC that have progressed or are intolerant to crizotinibConfirmed: the accelerated approval of 2017 converted to traditional approval 3.1 years after it was granted. |
| 19 May 2020 | Olaparib Small-molecule PARP inhibitor | Approval | US | HRR-mutant mCRPC (PROfound) source |
| 15 May 2020 | Approval | US | With nivolumab in first-line NSCLC (CheckMate 227) and HCC source | |
| 15 May 2020 | Ripretinib Small-molecule kinase inhibitor (KIT/PDGFRA switch-control) | Approval | US | INVICTUS |
| 15 May 2020 | Rucaparib Small-molecule PARP inhibitor | Accelerated approval | US | Treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. source |
| 14 May 2020 | Accelerated approval | US | Treatment of patients with AIDS-related Kaposi’s Sarcoma after failure of highly active antiretroviral therapy (HAART).Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 6.3 years later, when the FDA's table was read. | |
| 14 May 2020 | Accelerated approval | US | Treatment of Kaposi’s Sarcoma in patients who are HIV-negativeAccelerated approval on a surrogate endpoint; the confirmatory requirement was still open 6.3 years later, when the FDA's table was read. | |
| 8 May 2020 | Approval | US | With olaparib as HRD-positive maintenance (PAOLA-1) | |
| 8 May 2020 | Accelerated approval | US | Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy *Accelerated approval, RET-fusion NSCLC and thyroid cancer, RET-mutant MTC (LIBRETTO-001) source | |
| 8 May 2020 | Accelerated approval | US | Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) *Accelerated approval on a surrogate endpoint, with a confirmatory trial required. source | |
| 8 May 2020 | Accelerated approval | US | Adult patients with metastatic RET fusion-positive Non-Small Cell Lung Cancer (NSCLC)Accelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 6 May 2020 | Capmatinib Small-molecule MET tyrosine kinase inhibitor | Accelerated approval | US | Adult patients with mNSCLC whose tumors have a mutation that leads to MET exon 14 skipping as detected by an FDA-approved testAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 1 May 2020 | Approval | US | Subcutaneous Darzalex Faspro | |
| 29 Apr 2020 | Niraparib Small-molecule PARP inhibitor | Approval | US | First-line ovarian maintenance, all-comers (PRIMA) source |
| 28 Apr 2020 | Accelerated approval | US | Dosing Regimen: Alternative dose/schedule of 400mg every 6 weeks for adult patients with melanoma, hepatocellular carcinoma, Merkel cell carcinoma, gastric cancer, non-small cell lung cancer, renal cell carcinoma, endometrial carcinoma, cervical carcinoma, urothelial carcinoma, head and neck squamous cell carcinoma, small cell lung cancer, esophageal cancer, microsatellite instability-high or mismatch repair deficient solid tumorsAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 28 Apr 2020 | Accelerated approval | US | Dosing Regimen: Alternative dose/schedule of 400 mg every 6 weeks for adult patients with classical Hodgkin lymphoma and primary mediastinal b-cell lymphomaAccelerated approval on a surrogate endpoint; the confirmatory requirement was still open 6.4 years later, when the FDA's table was read. | |
| 22 Apr 2020 | Accelerated approval | US | Adults with metastatic TNBC following at least 2 prior therapies for metastatic diseaseAccelerated approval, metastatic TNBC after ≥2 prior therapies source | |
| 17 Apr 2020 | Pemigatinib Small-molecule kinase inhibitor (FGFR1-3) | Accelerated approval | US | Treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 6.4 years later, when the FDA's table was read. |
| 17 Apr 2020 | Tucatinib Small-molecule kinase inhibitor (HER2) | Approval | US | HER2+ metastatic breast cancer including brain metastases, with trastuzumab and capecitabine (HER2CLIMB) source |
| Apr 2020 | Cetuximab Monoclonal antibody (anti-EGFR) | Approval | US | With encorafenib for BRAF V600E mCRC (BEACON) |
| 8 Apr 2020 | Encorafenib Small-molecule kinase inhibitor (BRAF) | Approval | US | BRAF V600E metastatic CRC with cetuximab after prior therapy (BEACON) source |
| 27 Mar 2020 | Approval | US | Extensive-stage SCLC with chemotherapy (CASPIAN) source | |
| Mar 2020 | Signatera Tumour-informed ctDNA MRD test | Approval | US | Medicare coverage (MolDX) for stage II-III colorectal cancer source |
| 13 Mar 2020 | Accelerated approval | US | Formulation: Treatment of peripheral T-cell lymphoma in adults who have received at least one prior therapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 10 Mar 2020 | Accelerated approval | US | In combination with nivolumab, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenibAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 10 Mar 2020 | Accelerated approval | US | In combination with ipilimumab, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenibAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 25 Feb 2020 | Olaratumab Anti-PDGFR alpha monoclonal antibody, intravenous | Withdrawal | US | In combination with doxorubicin for adults with soft tissue sarcoma with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgeryWithdrawn: the indication came off the label 3.4 years after its accelerated approval. |
| 23 Jan 2020 | Tazemetostat Small-molecule EZH2 inhibitor | Accelerated approval | US | Treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resectionAccelerated approval, epithelioid sarcoma |
| 27 Dec 2019 | Olaparib Small-molecule PARP inhibitor | Approval | US | gBRCA metastatic pancreatic cancer maintenance (POLO) source |
| 20 Dec 2019 | Accelerated approval | US | Adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic settingAccelerated approval, HER2+ metastatic breast cancer after ≥2 anti-HER2 regimens (DESTINY-Breast01) source | |
| 18 Dec 2019 | Accelerated approval | US | Adults with locally advanced or metastatic urothelial cancer who received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant, locally advanced, or metastatic settingAccelerated approval, advanced urothelial cancer after platinum and PD-1/PD-L1 (EV-201) source | |
| Dec 2019 | Ciltacabtagene autoleucel CAR-T (BCMA) | Designation | US | Breakthrough Therapy designation source |
| 1 Dec 2019 | Enasidenib Small-molecule IDH2 inhibitor | Withdrawal | EU | Marketing application withdrawn after EMA objections on efficacy source |
| 21 Nov 2019 | Acalabrutinib Small-molecule covalent BTK inhibitor (second generation) | Approval | US | CLL/SLL |
| 14 Nov 2019 | Zanubrutinib Small-molecule covalent BTK inhibitor (second generation) | Accelerated approval | US | Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 6.8 years later, when the FDA's table was read. |
| 17 Sept 2019 | Accelerated approval | US | In combination with pembrolizumab for advanced endometrial carcinoma not MSI-H or dMMR, with progression following systemic therapy and not candidates for curative surgery or radiationAccelerated approval with pembrolizumab in endometrial cancer (KEYNOTE-146) | |
| 17 Sept 2019 | Accelerated approval | US | In combination with lenvatinib for advanced endometrial carcinoma not MSI-H or dMMR, with progression following systemic therapy and not candidates for curative surgery or radiationAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 15 Aug 2019 | Entrectinib Small-molecule TRK/ROS1/ALK TKI (CNS-penetrant) | Accelerated approval | US | Treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy . *Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 7.1 years later, when the FDA's table was read. source |
| 31 Jul 2019 | Confirmed | US | Relapsed/refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic leukemia following at least 2 chemotherapy regimensConfirmed: the accelerated approval of 2005 converted to traditional approval 13.8 years after it was granted. | |
| 3 Jul 2019 | Selinexor Small-molecule XPO1 (nuclear export) inhibitor | Accelerated approval | US | In combination with dexamethasone for adults with relapsed/refractory multiple myeloma after at least 4 prior therapies and refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti-CD38 monoclonal antibodyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 17 Jun 2019 | Accelerated approval | US | Metastatic SCLC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 14 Jun 2019 | Quizartinib Small-molecule kinase inhibitor (FLT3-ITD, type II) | Complete response letter | US | Complete response letter for relapsed/refractory indication (QuANTUM-R) |
| 10 Jun 2019 | Confirmed | US | Recurrent or metastatic head and neck squamous cell carcinoma that progressed on or after platinum-containing chemotherapyConfirmed: the accelerated approval of 2016 converted to traditional approval 2.8 years after it was granted. | |
| 10 Jun 2019 | Accelerated approval | US | In combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies.Accelerated approval with BR in R/R DLBCL | |
| 23 May 2019 | Optune / Optune Pax (TTFields) Device (tumour treating fields) | Approval | US | Humanitarian device exemption, malignant pleural mesothelioma source |
| May 2019 | Signatera Tumour-informed ctDNA MRD test | Designation | US | FDA Breakthrough Device designation source |
| 15 May 2019 | Venetoclax Small-molecule BCL-2 inhibitor | Approval | US | First-line CLL with obinutuzumab (CLL14) source |
| 3 May 2019 | Approval | US | Adjuvant treatment of HER2+ early breast cancer with residual disease (KATHERINE) source | |
| 12 Apr 2019 | Erdafitinib Small-molecule kinase inhibitor (pan-FGFR) | Accelerated approval | US | Treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC), that has: susceptible FGFR3 or FGFR2 genetic alterations, and progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA.Accelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 4 Apr 2019 | Approval | US | Men with HR+/HER2- breast cancer source | |
| 18 Mar 2019 | Atezolizumab Monoclonal antibody (anti-PD-L1) | Approval | US | Extensive-stage SCLC with chemotherapy (IMpower133) source |
| Mar 2019 | Atezolizumab Monoclonal antibody (anti-PD-L1) | Approval | US | Accelerated approval with nab-paclitaxel for PD-L1-positive (SP142 IC 1 percent or more) unresectable locally advanced or metastatic TNBC on IMpassion130 progression-free survival source |
| 8 Mar 2019 | Atezolizumab Monoclonal antibody (anti-PD-L1) | Accelerated approval | US | In combination with paclitaxel protein-bound for unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells of any intensity covering = 1% of the tumor area), as determined by an FDA-approved test.PD-L1+ metastatic TNBC with nab-paclitaxel (accelerated; IMpassion130) source |
| 7 Mar 2019 | Confirmed | US | Unresectable or metastatic melanoma and progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitorConfirmed: the accelerated approval of 2014 converted to traditional approval 4.2 years after it was granted. | |
| 7 Mar 2019 | Confirmed | US | In combination with ipilimumab for BRAF V600 wild-type unresectable or metastatic melanomaConfirmed: the accelerated approval of 2015 converted to traditional approval 3.4 years after it was granted. | |
| 7 Mar 2019 | Confirmed | US | 1) In combination with ipilimumab for unresectable or metastatic melanoma to remove the restriction for treatment of only patients with BRAF wild-type melanoma; 2) As a single agent for BRAF V600 mutation positive unresectable or metastatic melanoma to remove the restriction that such patients should have disease progression following ipilimumab and a BRAF inhibitorConfirmed: the accelerated approval of 2016 converted to traditional approval 3.1 years after it was granted. | |
| 28 Feb 2019 | Approval | US | Subcutaneous trastuzumab-hyaluronidase (Herceptin Hylecta) source | |
| 30 Jan 2019 | Pemetrexed Cytotoxic (antifolate) | Confirmed | US | In combination with pembrolizumab and carboplatin for first-line treatment of metastatic non-squamous NSCLCConfirmed: the accelerated approval of 2018 converted to traditional approval 0.7 years after it was granted. |
| 19 Dec 2018 | Olaparib Small-molecule PARP inhibitor | Approval | US | First-line maintenance in BRCA-mutated ovarian cancer (SOLO-1) source |
| 19 Dec 2018 | Accelerated approval | US | Treatment of adults and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC)Accelerated approval on a surrogate endpoint, with a confirmatory trial required. source | |
| 6 Dec 2018 | Lapatinib Small-molecule reversible HER2/EGFR kinase inhibitor | Confirmed | US | In combination with letrozole for post-menopausal women with HR-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicatedConfirmed: the accelerated approval of 2010 converted to traditional approval 8.9 years after it was granted. |
| 28 Nov 2018 | Gilteritinib Small-molecule kinase inhibitor (FLT3, type I) | Approval | US | ADMIRAL interim; full OS data 2019 |
| 26 Nov 2018 | Larotrectinib Small-molecule pan-TRK inhibitor (first generation) | Accelerated approval | US | Treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have no satisfactory alternative treatments or that have progressed following treatmentAccelerated approval on a surrogate endpoint, with a confirmatory trial required. source |
| 26 Nov 2018 | Larotrectinib Small-molecule pan-TRK inhibitor (first generation) | Accelerated approval | US | Formation: Treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have no satisfactory alternative treatments or that have progressed following treatmentAccelerated approval on a surrogate endpoint, with a confirmatory trial required. source |
| 21 Nov 2018 | Venetoclax Small-molecule BCL-2 inhibitor | Accelerated approval | US | In combination with azacitidine or decitabine or low-dose cytarabine for newly-diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapyNewly diagnosed AML in unfit patients with azacitidine/decitabine/LDAC (accelerated) source |
| 16 Nov 2018 | Approval | US | First-line CD30+ peripheral T-cell lymphoma with CHP (ECHELON-2) source | |
| 9 Nov 2018 | Accelerated approval | US | Treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenibAccelerated approval on a surrogate endpoint, with a confirmatory trial required. source | |
| 2 Nov 2018 | Lorlatinib Small-molecule kinase inhibitor (ALK/ROS1) | Accelerated approval | US | ALK-positive metastatic NSCLC that has progressed on: • Crizotinib and at least one other ALK inhibitor for metastatic disease; or • Alectinib as the first ALK inhibitor therapy for metastatic disease; or • Ceritinib as the first ALK inhibitor therapy for metastatic diseaseALK+ NSCLC after prior ALK TKIs (accelerated) source |
| 16 Oct 2018 | Talazoparib Small-molecule PARP inhibitor | Approval | US | gBRCA HER2-negative locally advanced/metastatic breast cancer (EMBRACA) source |
| 28 Sept 2018 | Approval | US | Advanced cutaneous squamous cell carcinoma: first systemic therapy approved for CSCC source | |
| 24 Sept 2018 | Duvelisib Small-molecule PI3Kδ/γ inhibitor | Accelerated approval | US | Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least 2 prior systemic therapiesAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 20 Aug 2018 | Confirmed | US | In combination with pemetrexed and carboplatin for first-line treatment of metastatic non-squamous NSCLCConfirmed: the accelerated approval of 2017 converted to traditional approval 1.3 years after it was granted. | |
| 16 Aug 2018 | Accelerated approval | US | Metastatic SCLC with progression after platinum-based chemotherapy and at least one other line of therapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 20 Jul 2018 | Ivosidenib Small-molecule IDH1 inhibitor | Approval | US | First IDH1 inhibitor |
| 18 Jul 2018 | Approval | US | Pre/perimenopausal women and with fulvestrant (MONALEESA-7/-3) source | |
| 10 Jul 2018 | Accelerated approval | US | In combination with nivolumab, is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or DNA mismatch repair deficient (dMMR), metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecanAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 10 Jul 2018 | Accelerated approval | US | In combination with ipilimumab, is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or DNA mismatch repair deficient (dMMR), metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecanAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 27 Jun 2018 | Binimetinib Small-molecule kinase inhibitor (MEK1/2) | Approval | US | Encorafenib + binimetinib approved for BRAF V600 melanoma |
| 27 Jun 2018 | Encorafenib Small-molecule kinase inhibitor (BRAF) | Approval | US | BRAF V600 melanoma with binimetinib (COLUMBUS) source |
| 13 Jun 2018 | Approval | US | First-line ovarian cancer (GOG-0218) | |
| 13 Jun 2018 | Accelerated approval | US | Adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma, or who have relapsed after 2 or more prior lines of therapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 12 Jun 2018 | Accelerated approval | US | Treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS >/=1) as determined by an FDA approved testAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 8 Jun 2018 | Venetoclax Small-molecule BCL-2 inhibitor | Confirmed | US | Chronic lymphocytic leukemia with 17P deletion as detected by an FDA-approved test, after at least one prior therapyCLL/SLL with rituximab (MURANO) source |
| 4 Jun 2018 | Pemetrexed Cytotoxic (antifolate) | Accelerated approval | US | In combination with pembrolizumab and carboplatin for first-line treatment of metastatic non-squamous NSCLCAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 3 Jun 2018 | Oncotype DX Gene-expression prognostic/predictive assay | Label change | US | TAILORx results define recurrence score ≤25 as chemotherapy-sparing source |
| May 2018 | Galleri Multi-cancer early detection blood test | Designation | US | FDA Breakthrough Device designation source |
| 18 Apr 2018 | Approval | US | First-line EGFR-mutant NSCLC (FLAURA) source | |
| 16 Apr 2018 | Approval | US | With nivolumab in RCC source | |
| 16 Apr 2018 | Approval | US | With ipilimumab, intermediate/poor-risk RCC (CheckMate 214) source | |
| 6 Apr 2018 | Rucaparib Small-molecule PARP inhibitor | Confirmed | US | Deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer treated with 2 or more chemotherapies 2Recurrent ovarian maintenance (ARIEL3) |
| 29 Mar 2018 | Blinatumomab Bispecific T-cell engager (CD19×CD3) | Accelerated approval | US | Treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children 1MRD-positive B-ALL: first approval based on MRD source |
| 20 Mar 2018 | Confirmed | US | Systemic anaplastic large cell lymphoma after failure of at least one multi-agent chemotherapy regimenFirst-line stage III/IV Hodgkin lymphoma with AVD (ECHELON-1) source | |
| Mar 2018 | Designation | US | Breakthrough Therapy designation source | |
| 26 Feb 2018 | Approval | US | With aromatase inhibitor first line (MONARCH 3) source | |
| 16 Feb 2018 | Approval | US | Unresectable stage III NSCLC after chemoradiation (PACIFIC) source | |
| 26 Jan 2018 | Lutetium-177 dotatate Radioligand therapy (beta) | Approval | US | SSTR+ gastroenteropancreatic NETs (NETTER-1) source |
| 12 Jan 2018 | Olaparib Small-molecule PARP inhibitor | Approval | US | gBRCA HER2-negative metastatic breast cancer (OlympiAD) source |
| 20 Dec 2017 | Confirmed | US | In combination with trastuzumab and docetaxel for neoadjuvant treatment of HER2-positive locally advanced inflammatory or early-stage breast cancer (either greater than 2 cm in diameter or node-positive) as part of a complete treatment regimen for early early breast cancerAdjuvant (APHINITY) | |
| 19 Dec 2017 | Accelerated approval | US | Adults with newly diagnosed chronic phase Philadelphia chromosome positive CMLAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 5 Dec 2017 | Confirmed | US | Progressive glioblastoma following prior therapyConfirmed: the accelerated approval of 2009 converted to traditional approval 8.6 years after it was granted. | |
| 1 Dec 2017 | Approval | US | First trastuzumab biosimilar (Ogivri) source | |
| 30 Nov 2017 | FoundationOne CDx / Liquid CDx Comprehensive genomic profiling test | Approval | US | FDA approval and parallel Medicare NCD: first FDA-approved broad CGP companion diagnostic source |
| 6 Nov 2017 | Confirmed | US | ALK-positive metastatic NSCLC that progressed on or is intolerant to crizotinibConfirmed: the accelerated approval of 2015 converted to traditional approval 1.9 years after it was granted. | |
| 31 Oct 2017 | Acalabrutinib Small-molecule covalent BTK inhibitor (second generation) | Accelerated approval | US | Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 18 Oct 2017 | Axicabtagene ciloleucel CAR-T (CD19) | Approval | US | Relapsed/refractory large B-cell lymphoma after ≥2 lines (ZUMA-1): second CAR-T ever approved source |
| 28 Sept 2017 | Approval | US | With fulvestrant after endocrine therapy, and as monotherapy after chemotherapy (MONARCH 2/1) source | |
| 26 Sept 2017 | Lutetium-177 dotatate Radioligand therapy (beta) | Approval | EU | EMA approval: first modern PRRT source |
| 22 Sept 2017 | Accelerated approval | US | Hepatocellular carcinoma previously treated with sorafenibAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 22 Sept 2017 | Accelerated approval | US | For patients with recurrent or locally advanced or metastatic gastric or GEJ adenocarcinoma whose tumors express PD-L1 [CPS ≥1] as determined by an FDA-approved test, with disease progression on/after two or more prior lines of therapy including fluoropyrimidine and platinum containing chemotherapy and if appropriate, HER2/NEU targeted therapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| Sept 2017 | Approval | US | First biosimilar (bevacizumab-awwb) approved | |
| 14 Sept 2017 | Copanlisib Intravenous pan-class I PI3K inhibitor (α/δ predominant) | Accelerated approval | US | Treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapiesAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 1 Sept 2017 | Approval | US | Re-approval at lower fractionated dose for newly diagnosed and relapsed CD33+ AML (ALFA-0701) source | |
| 30 Aug 2017 | Tisagenlecleucel CAR-T (CD19) | Approval | US | First CAR-T approval in history |
| 17 Aug 2017 | Approval | US | INO-VATE | |
| 17 Aug 2017 | Olaparib Small-molecule PARP inhibitor | Confirmed | US | Deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer after treatment with 3 or more lines of chemotherapy 2Maintenance in platinum-sensitive recurrent ovarian cancer; tablet formulation source |
| Aug 2017 | Designation | US | Breakthrough Therapy designation, HER2+ breast cancer source | |
| 3 Aug 2017 | CPX-351 (liposomal daunorubicin-cytarabine) Liposomal cytotoxic formulation | Approval | US | Adults |
| 1 Aug 2017 | Enasidenib Small-molecule IDH2 inhibitor | Approval | US | Single-arm AG221-C-001 |
| 31 Jul 2017 | Accelerated approval | US | For the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecanAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 11 Jul 2017 | Blinatumomab Bispecific T-cell engager (CD19×CD3) | Confirmed | US | Philadelphia chromosome negative relapsed or refractory B-cell precursor acute lymphoblastic leukemiaFull approval including Ph+ ALL source |
| 26 May 2017 | Ceritinib Small-molecule ALK TKI (second generation) | Confirmed | US | ALK-positive metastatic NSCLC that progressed on or is intolerant to crizotinibConfirmed: the accelerated approval of 2014 converted to traditional approval 3.1 years after it was granted. |
| 23 May 2017 | Accelerated approval | US | Treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or metastatic MSI-H or dMMR colorectal cancer that have progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecanMSI-H/dMMR solid tumours: first tumour-agnostic approval source | |
| 18 May 2017 | Accelerated approval | US | Locally advanced or metastatic urothelial carcinoma ineligible for cisplatin-containing chemotherapy 1Accelerated approval on a surrogate endpoint, with a confirmatory trial required. source | |
| May 2017 | Dinutuximab (ch14.18) / dinutuximab beta Monoclonal antibody (anti-GD2, chimeric) | Approval | EU | Dinutuximab beta (Qarziba) |
| 10 May 2017 | Accelerated approval | US | In combination with pemetrexed and carboplatin for first-line treatment of metastatic non-squamous NSCLCAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 9 May 2017 | Accelerated approval | US | Locally advanced or metastatic urothelial carcinoma following diease progression on platinum-containing chemotherapy or disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 1 May 2017 | Accelerated approval | US | Locally advanced or metastatic urothelial carcinoma that progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapyUrothelial carcinoma (accelerated; later withdrawn 2021) source | |
| 28 Apr 2017 | Brigatinib Small-molecule ALK/EGFR TKI (second generation) | Accelerated approval | US | Patients with ALK-positive metastatic NSCLC that have progressed or are intolerant to crizotinibAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 28 Apr 2017 | Midostaurin Small-molecule multikinase inhibitor (FLT3) | Approval | US | First FLT3 inhibitor approved |
| 25 Apr 2017 | Accelerated approval | US | Treatment of adult patients with classical Hodgkin lymphoma that has relapsed or progressed after: Autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, Or 3 or more lines of systemic therapy that includes autologous HSCTAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 17 Apr 2017 | Atezolizumab Monoclonal antibody (anti-PD-L1) | Accelerated approval | US | Patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 as determined by an FDA approved test or who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 statusAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 31 Mar 2017 | Confirmed | US | In combination with letrozole for postmenopausal women with ER-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy for metastatic diseaseFull approval (PALOMA-2) source | |
| 30 Mar 2017 | Confirmed | US | Metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, that progressed on or after EGFR TKI therapyFull approval (AURA3) source | |
| 27 Mar 2017 | Niraparib Small-molecule PARP inhibitor | Approval | US | Maintenance in recurrent ovarian cancer regardless of BRCA (NOVA) source |
| 23 Mar 2017 | Accelerated approval | US | Treatment of adults and pediatrics patients 12 years and older with metastatic merkel cell carcinoma (MCC)Accelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 14 Mar 2017 | Accelerated approval | US | Adult and pediatric patients with refractory classical Hodgkin Lymphoma or who have relapsed after 3 or more prior lines of therapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 13 Mar 2017 | Approval | US | With aromatase inhibitor, HR+/HER2- advanced breast cancer (MONALEESA-2) source | |
| 2 Feb 2017 | Accelerated approval | US | Locally advanced or metastatic urothelial carcinoma that: • progressed during or following platinum-containing chemotherapy • progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 18 Jan 2017 | Accelerated approval | US | Adult patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 19 Dec 2016 | Rucaparib Small-molecule PARP inhibitor | Accelerated approval | US | Deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer treated with 2 or more chemotherapies 2Accelerated approval, gBRCA/sBRCA ovarian, ≥2 prior lines |
| 28 Nov 2016 | Ponatinib Small-molecule kinase inhibitor (pan-BCR::ABL1 incl. T315I) | Confirmed | US | Adults with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia resistant or intolerant to TKI therapy or or Philadelphia chromosome positive acute lymphoblastic leukemia resistant or intolerant to prior TKI therapyConfirmed: the accelerated approval of 2012 converted to traditional approval 4.0 years after it was granted. |
| 21 Nov 2016 | Confirmed | US | Multiple myeloma after at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or double refractory to a proteasome inhibitor and an immunomodulatory agentConfirmed: the accelerated approval of 2015 converted to traditional approval 1.0 year after it was granted. | |
| 24 Oct 2016 | Confirmed | US | Metastatic PD-L1 positive NSCLC, as determined by an FDA-approved test, with progression on or after platinum-containing chemotherapyConfirmed: the accelerated approval of 2015 converted to traditional approval 1.1 years after it was granted. | |
| 19 Oct 2016 | Olaratumab Anti-PDGFR alpha monoclonal antibody, intravenous | Accelerated approval | US | In combination with doxorubicin for adults with soft tissue sarcoma with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgeryAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 18 Oct 2016 | Atezolizumab Monoclonal antibody (anti-PD-L1) | Approval | US | NSCLC after platinum source |
| 5 Aug 2016 | Accelerated approval | US | Recurrent or metastatic head and neck squamous cell carcinoma that progressed on or after platinum-containing chemotherapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 18 May 2016 | Atezolizumab Monoclonal antibody (anti-PD-L1) | Accelerated approval | US | Locally advanced or metastatic urothelial carcinoma that progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapyUrothelial carcinoma after platinum (accelerated; later withdrawn) source |
| 17 May 2016 | Accelerated approval | US | For the treatment of classical Hodgkin Lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotinAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 11 Apr 2016 | Venetoclax Small-molecule BCL-2 inhibitor | Accelerated approval | US | Chronic lymphocytic leukemia with 17P deletion as detected by an FDA-approved test, after at least one prior therapyCLL with 17p deletion after ≥1 therapy: first BCL-2 inhibitor source |
| 4 Mar 2016 | Approval | US | First-line CLL | |
| 19 Feb 2016 | Approval | US | With fulvestrant after endocrine therapy (PALOMA-3) source | |
| 18 Feb 2016 | Confirmed | US | Adults with renal angiomyolipma and tuberous sclerosis complex not requiring immediate surgeryConfirmed: the accelerated approval of 2012 converted to traditional approval 3.8 years after it was granted. | |
| 5 Feb 2016 | Designation | US | Breakthrough Therapy designation for pretreated metastatic TNBC source | |
| 1 Feb 2016 | Approval | US | First US generic imatinib launched source | |
| 29 Jan 2016 | Confirmed | US | Patients with subependymal giant cell astrocytoma associated with tuberous sclerosis who require therapeutic intervention but are not candidates for curative surgical resectionConfirmed: the accelerated approval of 2010 converted to traditional approval 5.3 years after it was granted. | |
| 29 Jan 2016 | Confirmed | US | Formulation: Pediatric and adult patients with tuberous sclerosis complex for treatment of subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be curatively resectedConfirmed: the accelerated approval of 2012 converted to traditional approval 3.4 years after it was granted. | |
| 23 Jan 2016 | Accelerated approval | US | 1) In combination with ipilimumab for unresectable or metastatic melanoma to remove the restriction for treatment of only patients with BRAF wild-type melanoma; 2) As a single agent for BRAF V600 mutation positive unresectable or metastatic melanoma to remove the restriction that such patients should have disease progression following ipilimumab and a BRAF inhibitorAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 21 Jan 2016 | Confirmed | US | Multiple myeloma after at least 2 prior therapies including bortezomib and an immunomodulatory agent and disease progression on or within 60 days of completion of the last therapyConfirmed: the accelerated approval of 2012 converted to traditional approval 3.5 years after it was granted. | |
| 18 Dec 2015 | Confirmed | US | Unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitorConfirmed: the accelerated approval of 2014 converted to traditional approval 1.3 years after it was granted. | |
| Dec 2015 | Talimogene laherparepvec Oncolytic virus (HSV-1) | Approval | EU | EMA approval source |
| 11 Dec 2015 | Accelerated approval | US | ALK-positive metastatic NSCLC that progressed on or is intolerant to crizotinibAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 20 Nov 2015 | Dabrafenib Small-molecule BRAF kinase inhibitor | Confirmed | US | In combination with trametinib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved testConfirmed: the accelerated approval of 2014 converted to traditional approval 1.9 years after it was granted. |
| 20 Nov 2015 | Trametinib Small-molecule allosteric MEK1/2 inhibitor | Confirmed | US | In combination with dabrafenib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved testConfirmed: the accelerated approval of 2014 converted to traditional approval 1.9 years after it was granted. |
| 16 Nov 2015 | Accelerated approval | US | Multiple myeloma after at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or double refractory to a proteasome inhibitor and an immunomodulatory agentFirst CD38 antibody | |
| 13 Nov 2015 | Accelerated approval | US | Metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, that progressed on or after EGFR TKI therapyAccelerated approval, EGFR T790M NSCLC after TKI source | |
| 10 Nov 2015 | Approval | US | Cobimetinib approved in combination (coBRIM) | |
| 28 Oct 2015 | Approval | US | Adjuvant stage III melanoma (10 mg/kg; later superseded) source | |
| 27 Oct 2015 | Talimogene laherparepvec Oncolytic virus (HSV-1) | Approval | US | Unresectable melanoma with injectable lesions (OPTiM): first oncolytic virus approved in the US source |
| 5 Oct 2015 | Optune / Optune Pax (TTFields) Device (tumour treating fields) | Approval | US | Newly diagnosed glioblastoma with temozolomide (EF-14) source |
| 2 Oct 2015 | Accelerated approval | US | Metastatic PD-L1 positive NSCLC, as determined by an FDA-approved test, with progression on or after platinum-containing chemotherapyPD-L1+ NSCLC after platinum source | |
| 1 Oct 2015 | Approval | US | With ipilimumab, BRAF wild-type melanoma (CheckMate 067) source | |
| 30 Sept 2015 | Accelerated approval | US | In combination with ipilimumab for BRAF V600 wild-type unresectable or metastatic melanomaAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| Sept 2015 | Trifluridine/tipiracil Cytotoxic chemotherapy (oral nucleoside) | Approval | US | RECOURSE |
| 17 Aug 2015 | Confirmed | US | Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT), or after failure of at least 2 multi-agent chemotherapy regimens in patients who are not ASCT candidatesPost-transplant consolidation in Hodgkin lymphoma (AETHERA) source | |
| 12 Aug 2015 | Confirmed | US | Newly diagnosed adults with Philadelphia chromosome-positive CML in chronic phaseConfirmed: the accelerated approval of 2010 converted to traditional approval 4.8 years after it was granted. | |
| 23 Apr 2015 | Confirmed | US | Multiple myeloma after at least 2 prior therapies including lenalidomide and bortezomib and disease progression on or within 60 days of completion of the last therapyConfirmed: the accelerated approval of 2013 converted to traditional approval 2.2 years after it was granted. | |
| 10 Mar 2015 | Dinutuximab (ch14.18) / dinutuximab beta Monoclonal antibody (anti-GD2, chimeric) | Approval | US | Unituxin (ANBL0032) |
| 4 Mar 2015 | Approval | US | Squamous NSCLC after platinum: first PD-1 in lung cancer source | |
| 23 Feb 2015 | Panobinostat Pan-HDAC inhibitor | Accelerated approval | US | In combination with bortezomib (BTZ) and dexamethasone (DEX) for the treatment of patients with multiple myeloma (MM) who have received at least 2 prior regimens, including BTZ and an immunomodulatory agent.Accelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 3 Feb 2015 | Accelerated approval | US | In combination with letrozole for postmenopausal women with ER-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy for metastatic diseaseAccelerated approval with letrozole: first CDK4/6 inhibitor (PALOMA-1) source | |
| 27 Jan 2015 | Confirmed | US | Newly diagnosed adults with with Philadelphia chromosome-positive CML in chronic phaseConfirmed: the accelerated approval of 2010 converted to traditional approval 4.6 years after it was granted. | |
| 22 Dec 2014 | Accelerated approval | US | Unresectable or metastatic melanoma and progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitorAdvanced melanoma after ipilimumab (accelerated) source | |
| 19 Dec 2014 | Olaparib Small-molecule PARP inhibitor | Accelerated approval | US | Deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer after treatment with 3 or more lines of chemotherapy 2gBRCA advanced ovarian cancer after ≥3 lines: first PARP inhibitor source |
| 10 Dec 2014 | Nonavalent HPV vaccine Prophylactic vaccine (virus-like particles) | Approval | US | Gardasil 9 approved |
| 3 Dec 2014 | Blinatumomab Bispecific T-cell engager (CD19×CD3) | Accelerated approval | US | Philadelphia chromosome negative relapsed or refractory B-cell precursor acute lymphoblastic leukemiaAccelerated approval, Ph-negative relapsed/refractory B-ALL: first BiTE source |
| 4 Sept 2014 | Accelerated approval | US | Unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitorAccelerated approval, advanced melanoma after ipilimumab; first PD-1 inhibitor in the US source | |
| 14 Aug 2014 | Approval | US | Cervical cancer with chemotherapy (GOG-0240) | |
| 28 Jul 2014 | Confirmed | US | Chronic lymphocytic leukemia after at least one prior therapyConfirmed: the accelerated approval of 2014 converted to traditional approval 0.5 years after it was granted. | |
| 23 Jul 2014 | Idelalisib Small-molecule PI3Kδ inhibitor | Accelerated approval | US | For the treatment of relapsed follicular B-cell Non-Hodgkin Lymphoma (FL) in patients who have received at least 2 prior systemic therapies and relapsed small lymphocytic lymphoma (SLL) in patients who have received at least 2 prior systemic therapiesAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 4 Jul 2014 | Approval | JP | First PD-1 inhibitor approved worldwide (melanoma, Japan) source | |
| 3 Jul 2014 | Belinostat Pan-HDAC inhibitor (hydroxamate) | Accelerated approval | US | Treatment of relapsed or refractory peripheral T-Cell Lymphoma (PTCL)Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 12.2 years later, when the FDA's table was read. |
| 19 Jun 2014 | Confirmed | US | Newly diagnosed multiple myelomaConfirmed: the accelerated approval of 2006 converted to traditional approval 8.1 years after it was granted. | |
| 23 May 2014 | Panitumumab Monoclonal antibody (anti-EGFR) | Confirmed | US | EGFR-expressing metastatic colorectal carcinoma with progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimensConfirmed: the accelerated approval of 2006 converted to traditional approval 7.7 years after it was granted. |
| May 2014 | Panitumumab Monoclonal antibody (anti-EGFR) | Label change | US | First-line with FOLFOX in RAS wild-type (PRIME) |
| 29 Apr 2014 | Ceritinib Small-molecule ALK TKI (second generation) | Accelerated approval | US | ALK-positive metastatic NSCLC that progressed on or is intolerant to crizotinibAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 17 Apr 2014 | Ofatumumab Monoclonal antibody (anti-CD20, fully human IgG1) | Confirmed | US | Chronic lymphocytic leukemia refractory to fludarabine and alemtuzumabConfirmed: the accelerated approval of 2009 converted to traditional approval 4.5 years after it was granted. |
| 12 Feb 2014 | Accelerated approval | US | Chronic lymphocytic leukemia after at least one prior therapyRelapsed CLL | |
| 10 Feb 2014 | Omacetaxine mepesuccinate Protein synthesis inhibitor (cephalotaxine ester) | Confirmed | US | Adults with chronic or accelerated phase chronic myeloid leukemia with resistance or intolerance to 2 or more TKIsConfirmed: the accelerated approval of 2012 converted to traditional approval 1.3 years after it was granted. |
| 9 Jan 2014 | Dabrafenib Small-molecule BRAF kinase inhibitor | Accelerated approval | US | In combination with trametinib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved testAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 8 Jan 2014 | Trametinib Small-molecule allosteric MEK1/2 inhibitor | Accelerated approval | US | In combination with dabrafenib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved testAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 20 Nov 2013 | Crizotinib Small-molecule ALK/ROS1/MET TKI (first generation) | Confirmed | US | Locally advanced or metastatic NSCLC that is ALK-positive as detected by an FDA-approved testConfirmed: the accelerated approval of 2011 converted to traditional approval 2.2 years after it was granted. |
| 13 Nov 2013 | Accelerated approval | US | Adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapyMantle cell lymphoma (accelerated); first BTK inhibitor | |
| 31 Oct 2013 | Ponatinib Small-molecule kinase inhibitor (pan-BCR::ABL1 incl. T315I) | Withdrawal | US | Temporary marketing suspension for arterial occlusion; returned with narrowed label December 2013 |
| 30 Sept 2013 | Accelerated approval | US | In combination with trastuzumab and docetaxel for neoadjuvant treatment of HER2-positive locally advanced inflammatory or early-stage breast cancer (either greater than 2 cm in diameter or node-positive) as part of a complete treatment regimen for early early breast cancerNeoadjuvant accelerated approval on pCR | |
| 6 Sept 2013 | Approval | US | nab-Paclitaxel with gemcitabine for metastatic pancreatic cancer source | |
| 22 Feb 2013 | Approval | US | HER2+ metastatic breast cancer after trastuzumab and taxane (EMILIA); first ADC for a solid tumour source | |
| 8 Feb 2013 | Accelerated approval | US | Multiple myeloma after at least 2 prior therapies including lenalidomide and bortezomib and disease progression on or within 60 days of completion of the last therapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 14 Dec 2012 | Ponatinib Small-molecule kinase inhibitor (pan-BCR::ABL1 incl. T315I) | Accelerated approval | US | Adults with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia resistant or intolerant to TKI therapy or or Philadelphia chromosome positive acute lymphoblastic leukemia resistant or intolerant to prior TKI therapyResistant CML/Ph+ ALL |
| 26 Oct 2012 | Omacetaxine mepesuccinate Protein synthesis inhibitor (cephalotaxine ester) | Accelerated approval | US | Adults with chronic or accelerated phase chronic myeloid leukemia with resistance or intolerance to 2 or more TKIsAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 29 Aug 2012 | Accelerated approval | US | Formulation: Pediatric and adult patients with tuberous sclerosis complex for treatment of subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be curatively resectedAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 9 Aug 2012 | Vincristine Vinca alkaloid (microtubule inhibitor) | Accelerated approval | US | Adults with Philadelphia (PH) chromosome negative (-) ALL in second relapse or greater relapsed or whose disease has progressed following 2 or greater treatment lines of anti-leukemia therapiesAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 20 Jul 2012 | Accelerated approval | US | Multiple myeloma after at least 2 prior therapies including bortezomib and an immunomodulatory agent and disease progression on or within 60 days of completion of the last therapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| Jul 2012 | Cetuximab Monoclonal antibody (anti-EGFR) | Label change | US | Label restricted to KRAS wild-type; first-line FOLFIRI indication (CRYSTAL) |
| 6 Jul 2012 | Cetuximab Monoclonal antibody (anti-EGFR) | Confirmed | US | In combination with irinotecan for EGFR-expressing metastatic colorectal carcinoma refractory to irinotecan-based chemotherapyConfirmed: the accelerated approval of 2004 converted to traditional approval 8.4 years after it was granted. |
| 8 Jun 2012 | Withdrawal | US | To reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis patients, as an adjunct to usual careWithdrawn: the indication came off the label 12.5 years after its accelerated approval. | |
| 8 Jun 2012 | Approval | US | First-line metastatic (CLEOPATRA) | |
| 26 Apr 2012 | Accelerated approval | US | Adults with renal angiomyolipma and tuberous sclerosis complex not requiring immediate surgeryAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 25 Apr 2012 | Gefitinib Small-molecule EGFR TKI (first generation, reversible) | Withdrawal | US | As monotherapy for locally advanced or metastatic NSCLC after failure of platinum-based and docetaxel chemotherapyWithdrawn: the indication came off the label 9.0 years after its accelerated approval. |
| 31 Jan 2012 | Confirmed | US | Adjuvant treatment of adults following complete gross resection of KIT (CD117) positive gastrointestinal stromal tumors (GIST)Confirmed: the accelerated approval of 2008 converted to traditional approval 3.1 years after it was granted. | |
| 31 Dec 2011 | Withdrawal | US | For adults with B-cell CLL that has not responded to or progressed during or after treatment with at least one standard alkylating agent containing regimenWithdrawn: the indication came off the label 3.0 years after its accelerated approval. | |
| 28 Nov 2011 | Withdrawal | US | For patients with CD33+ AML in first relapse 60 years of age or older and not candidates for cytotoxic chemotherapyWithdrawn: the indication came off the label 11.5 years after its accelerated approval. | |
| 18 Nov 2011 | Withdrawal | US | In combination with paclitaxel for patients who have not received chemotherapy for metastatic HER2 negative breast cancerWithdrawn: the indication came off the label 3.7 years after its accelerated approval. | |
| 26 Aug 2011 | Crizotinib Small-molecule ALK/ROS1/MET TKI (first generation) | Accelerated approval | US | Locally advanced or metastatic NSCLC that is ALK-positive as detected by an FDA-approved testAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 19 Aug 2011 | Accelerated approval | US | Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT), or after failure of at least 2 multi-agent chemotherapy regimens in patients who are not ASCT candidatesAccelerated approval, relapsed Hodgkin lymphoma and systemic ALCL source | |
| 19 Aug 2011 | Accelerated approval | US | Systemic anaplastic large cell lymphoma after failure of at least one multi-agent chemotherapy regimenAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 17 Aug 2011 | Approval | US | Approved with the cobas BRAF V600 companion test, the first melanoma targeted therapy | |
| 16 Jun 2011 | Accelerated approval | US | Peripheral T-cell lymphoma in patients who have received at least one prior therapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 8 Apr 2011 | Optune / Optune Pax (TTFields) Device (tumour treating fields) | Approval | US | PMA approval, recurrent glioblastoma source |
| 6 Apr 2011 | Vandetanib Small-molecule kinase inhibitor (RET, VEGFR, EGFR) | Approval | US | First approval for medullary thyroid cancer |
| 1 Apr 2011 | Confirmed | US | Newly diagnosed Philadelphia positive CML in pediatric patientsConfirmed: the accelerated approval of 2006 converted to traditional approval 4.5 years after it was granted. | |
| 25 Mar 2011 | Approval | US | Metastatic melanoma: first checkpoint inhibitor approved anywhere source | |
| 14 Jan 2011 | Confirmed | US | Chronic phase and accelerated phase Philadelphia chromosome positive CML in adults resistant or intolerant to prior therapy that included Gleevec (imatinib)Confirmed: the accelerated approval of 2007 converted to traditional approval 3.2 years after it was granted. | |
| 29 Oct 2010 | Accelerated approval | US | Patients with subependymal giant cell astrocytoma associated with tuberous sclerosis who require therapeutic intervention but are not candidates for curative surgical resectionAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 28 Oct 2010 | Accelerated approval | US | Newly diagnosed adults with Philadelphia chromosome-positive CML in chronic phaseAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 20 Oct 2010 | Approval | US | HER2+ metastatic gastric cancer (ToGA) source | |
| 21 Jun 2010 | Withdrawal | US | Voluntary withdrawal after confirmatory trial showed no benefit and excess deaths source | |
| 17 Jun 2010 | Accelerated approval | US | Newly diagnosed adults with with Philadelphia chromosome-positive CML in chronic phaseAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 30 Apr 2010 | Confirmed | US | Extended adjuvant treatment of early breast cancer in postmenopausal women who received 5 years of adjuvant tamoxifenConfirmed: the accelerated approval of 2004 converted to traditional approval 5.5 years after it was granted. | |
| 30 Apr 2010 | Confirmed | US | Postmenopausal women with HR positive early breast cancerConfirmed: the accelerated approval of 2005 converted to traditional approval 4.3 years after it was granted. | |
| 29 Jan 2010 | Lapatinib Small-molecule reversible HER2/EGFR kinase inhibitor | Accelerated approval | US | In combination with letrozole for post-menopausal women with HR-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicatedAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 26 Oct 2009 | Ofatumumab Monoclonal antibody (anti-CD20, fully human IgG1) | Accelerated approval | US | Chronic lymphocytic leukemia refractory to fludarabine and alemtuzumabAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 24 Sept 2009 | Pralatrexate Antifolate (DHFR inhibitor) | Accelerated approval | US | Treatment of relapsed or refractory peripheral T-Cell Lymphoma (PTCL)Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 17.0 years later, when the FDA's table was read. |
| 3 Sept 2009 | Ibritumomab tiuxetan Radioimmunotherapy (yttrium-90 labelled anti-CD20 antibody) | Confirmed | US | Relapsed or refractory low-grade follicular or transformed B-cell NHL other than rituximab-refractory follicular NHLConfirmed: the accelerated approval of 2002 converted to traditional approval 7.5 years after it was granted. |
| 2 Jul 2009 | Pemetrexed Cytotoxic (antifolate) | Confirmed | US | As a single agent for locally advanced or metastatic NSCLC after prior chemotherapyConfirmed: the accelerated approval of 2004 converted to traditional approval 4.9 years after it was granted. |
| 2 Jul 2009 | Pemetrexed Cytotoxic (antifolate) | Confirmed | US | Non-squamous NSCLC: 1) as initial treatment with cisplatin; 2) as a single agent after prior chemotherapyConfirmed: the accelerated approval of 2008 converted to traditional approval 0.8 years after it was granted. |
| 27 May 2009 | Confirmed | US | Newly diagnosed adults with Philadelphia chromosome positive CMLConfirmed: the accelerated approval of 2002 converted to traditional approval 6.4 years after it was granted. | |
| 21 May 2009 | Confirmed | US | Chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinibConfirmed: the accelerated approval of 2006 converted to traditional approval 2.9 years after it was granted. | |
| 5 May 2009 | Accelerated approval | US | Progressive glioblastoma following prior therapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 19 Dec 2008 | Accelerated approval | US | Adjuvant treatment of adults following complete gross resection of KIT (CD117) positive gastrointestinal stromal tumors (GIST)Adjuvant GIST source | |
| 18 Dec 2008 | Accelerated approval | US | For adults with B-cell CLL that has not responded to or progressed during or after treatment with at least one standard alkylating agent containing regimenAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 15 Oct 2008 | Denileukin diftitox IL-2 receptor-directed cytotoxin (fusion protein) | Confirmed | US | Persistent or recurrent cutaneous T-cell lymphoma expressing the CD25 component of IL-2 receptorConfirmed: the accelerated approval of 1999 converted to traditional approval 9.7 years after it was granted. |
| 26 Sept 2008 | Confirmed | US | KIT (CD117) positive unresectable and/or metastatic GISTConfirmed: the accelerated approval of 2002 converted to traditional approval 6.7 years after it was granted. | |
| 26 Sept 2008 | Pemetrexed Cytotoxic (antifolate) | Accelerated approval | US | Non-squamous NSCLC: 1) as initial treatment with cisplatin; 2) as a single agent after prior chemotherapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 10 Jun 2008 | Pegylated liposomal doxorubicin Cytotoxic (liposomal anthracycline) | Confirmed | US | Kaposi's sarcoma in AIDS patients with disease progression on prior combination chemotherapy or who are intolerant to such therapyConfirmed: the accelerated approval of 1995 converted to traditional approval 12.6 years after it was granted. |
| 22 Feb 2008 | Accelerated approval | US | In combination with paclitaxel for patients who have not received chemotherapy for metastatic HER2 negative breast cancerAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 16 Nov 2007 | Sorafenib Small-molecule multi-kinase inhibitor (VEGFR, PDGFR, RAF) | Approval | US | Unresectable HCC on SHARP |
| 29 Oct 2007 | Accelerated approval | US | Chronic phase and accelerated phase Philadelphia chromosome positive CML in adults resistant or intolerant to prior therapy that included Gleevec (imatinib)Accelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 2 Oct 2007 | Cetuximab Monoclonal antibody (anti-EGFR) | Confirmed | US | As a single agent for EGFR-expressing metastatic colorectal carcinoma intolerant to irinotecan-based chemotherapyConfirmed: the accelerated approval of 2004 converted to traditional approval 3.6 years after it was granted. |
| 19 Sept 2007 | Alemtuzumab Monoclonal antibody (anti-CD52) | Confirmed | US | B-cell CLL treated with alkylating agents and failed fludarabine therapyConfirmed: the accelerated approval of 2001 converted to traditional approval 6.4 years after it was granted. |
| 19 Apr 2007 | Confirmed | US | Intrathecal treatment of lymphomatous meningitisConfirmed: the accelerated approval of 1999 converted to traditional approval 8.0 years after it was granted. | |
| 2 Feb 2007 | Sunitinib Small-molecule multi-kinase inhibitor (VEGFR, PDGFR, KIT) | Confirmed | US | Advanced renal cell carcinomaConfirmed: the accelerated approval of 2006 converted to traditional approval 1.0 year after it was granted. |
| 16 Nov 2006 | Approval | US | Adjuvant HER2+ early breast cancer (HERA, NSABP B-31/N9831) source | |
| 27 Sept 2006 | Accelerated approval | US | Newly diagnosed Philadelphia positive CML in pediatric patientsAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 27 Sept 2006 | Confirmed | US | Pediatric patients with recurrent PH+ chronic phase CML after stem cell transplant or who are resistant to interferon alpha therapyConfirmed: the accelerated approval of 2003 converted to traditional approval 3.4 years after it was granted. | |
| 27 Sept 2006 | Panitumumab Monoclonal antibody (anti-EGFR) | Accelerated approval | US | EGFR-expressing metastatic colorectal carcinoma with progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimensAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| Sept 2006 | Panitumumab Monoclonal antibody (anti-EGFR) | Approval | US | Accelerated approval, refractory mCRC |
| 29 Jun 2006 | Approval | US | Myeloma with dexamethasone | |
| 28 Jun 2006 | Accelerated approval | US | Chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinibAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 8 Jun 2006 | Nonavalent HPV vaccine Prophylactic vaccine (virus-like particles) | Approval | US | Original quadrivalent Gardasil approved |
| 25 May 2006 | Accelerated approval | US | Newly diagnosed multiple myelomaAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 26 Jan 2006 | Sunitinib Small-molecule multi-kinase inhibitor (VEGFR, PDGFR, KIT) | Accelerated approval | US | Advanced renal cell carcinomaAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 28 Dec 2005 | Accelerated approval | US | Postmenopausal women with HR positive early breast cancerLetrozole adjuvant indication | |
| 27 Dec 2005 | Approval | US | MDS del(5q) | |
| 28 Oct 2005 | Accelerated approval | US | Relapsed/refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic leukemia following at least 2 chemotherapy regimensAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 16 Sept 2005 | Anastrozole Oral non-steroidal aromatase inhibitor | Confirmed | US | Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancerConfirmed: the accelerated approval of 2002 converted to traditional approval 3.0 years after it was granted. |
| 25 Mar 2005 | Bortezomib Proteasome inhibitor | Confirmed | US | Multiple myeloma patients who received at least two prior therapies and demontrated disease progression on the last therapyConfirmed: the accelerated approval of 2003 converted to traditional approval 1.9 years after it was granted. |
| 15 Mar 2005 | Temozolomide Oral alkylating chemotherapy | Confirmed | US | Adults with refractory anaplastic astrocytomaConfirmed: the accelerated approval of 1999 converted to traditional approval 5.6 years after it was granted. |
| 28 Jan 2005 | Pegylated liposomal doxorubicin Cytotoxic (liposomal anthracycline) | Confirmed | US | Metastatic ovarian carcinoma refractory to paclitaxel and platinum-based chemotherapyConfirmed: the accelerated approval of 1999 converted to traditional approval 5.6 years after it was granted. |
| 7 Jan 2005 | Approval | US | nab-Paclitaxel (Abraxane) for metastatic breast cancer source | |
| 28 Dec 2004 | Clofarabine Purine nucleoside analogue (antimetabolite) | Accelerated approval | US | Treatment of pediatric patients 1 to 21 yrs old with relapsed or refractory acute lymphocytic leukemia (ALL) after at least 2 prior regimensAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 29 Oct 2004 | Accelerated approval | US | Extended adjuvant treatment of early breast cancer in postmenopausal women who received 5 years of adjuvant tamoxifenAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 19 Aug 2004 | Pemetrexed Cytotoxic (antifolate) | Accelerated approval | US | As a single agent for locally advanced or metastatic NSCLC after prior chemotherapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 2004 | Carboplatin Cytotoxic chemotherapy (platinum) | Approval | US | First generics source |
| 19 May 2004 | Approval | US | First hypomethylating agent approved (MDS) | |
| Feb 2004 | Approval | US | First anti-angiogenic approval (AVF2107) | |
| Feb 2004 | Cetuximab Monoclonal antibody (anti-EGFR) | Approval | US | Initial approval in EGFR-expressing mCRC (BOND trial) |
| 12 Feb 2004 | Cetuximab Monoclonal antibody (anti-EGFR) | Accelerated approval | US | In combination with irinotecan for EGFR-expressing metastatic colorectal carcinoma refractory to irinotecan-based chemotherapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 12 Feb 2004 | Cetuximab Monoclonal antibody (anti-EGFR) | Accelerated approval | US | As a single agent for EGFR-expressing metastatic colorectal carcinoma intolerant to irinotecan-based chemotherapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| Jan 2004 | Oncotype DX Gene-expression prognostic/predictive assay | Filing / deal | US | Launched as a laboratory-developed test source |
| 9 Jan 2004 | Oxaliplatin Third-generation platinum (DACH-platinum) | Confirmed | US | In combination with infusional 5-FU/LV for metastatic color or rectal carcinoma that progressed during or within 6 months of completion of first-line therapy with bolus 5 -FU/LV and irinotectanConfirmed: the accelerated approval of 2002 converted to traditional approval 1.4 years after it was granted. |
| 8 Dec 2003 | Confirmed | US | CML in blast crisis, accelerated phase, or in chronic phase after failure of of interferon-alphaConfirmed: the accelerated approval of 2001 converted to traditional approval 2.6 years after it was granted. | |
| 20 May 2003 | Accelerated approval | US | Pediatric patients with recurrent PH+ chronic phase CML after stem cell transplant or who are resistant to interferon alpha therapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 13 May 2003 | Bortezomib Proteasome inhibitor | Accelerated approval | US | Multiple myeloma patients who received at least two prior therapies and demontrated disease progression on the last therapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 5 May 2003 | Gefitinib Small-molecule EGFR TKI (first generation, reversible) | Accelerated approval | US | As monotherapy for locally advanced or metastatic NSCLC after failure of platinum-based and docetaxel chemotherapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 20 Dec 2002 | Accelerated approval | US | Newly diagnosed adults with Philadelphia chromosome positive CMLAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 31 Oct 2002 | Dexrazoxane Cardioprotectant and extravasation antidote (bisdioxopiperazine) | Confirmed | US | Supportive Care: Prevention of cardiomyopathy associated with doxorubicin administrationConfirmed: the accelerated approval of 1995 converted to traditional approval 7.4 years after it was granted. |
| 5 Sept 2002 | Anastrozole Oral non-steroidal aromatase inhibitor | Accelerated approval | US | Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancerAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 9 Aug 2002 | Oxaliplatin Third-generation platinum (DACH-platinum) | Accelerated approval | US | In combination with infusional 5-FU/LV for metastatic color or rectal carcinoma that progressed during or within 6 months of completion of first-line therapy with bolus 5 -FU/LV and irinotectanAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 19 Feb 2002 | Ibritumomab tiuxetan Radioimmunotherapy (yttrium-90 labelled anti-CD20 antibody) | Accelerated approval | US | Relapsed or refractory low-grade follicular or transformed B-cell NHL other than rituximab-refractory follicular NHLAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 1 Feb 2002 | Accelerated approval | US | KIT (CD117) positive unresectable and/or metastatic GISTKIT+ gastrointestinal stromal tumour source | |
| 7 Sept 2001 | Confirmed | US | Metastatic breast cancer resistant to paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and further anthracycline therapy is contraindicatedConfirmed: the accelerated approval of 1998 converted to traditional approval 3.4 years after it was granted. | |
| 10 May 2001 | Accelerated approval | US | CML in blast crisis, accelerated phase, or in chronic phase after failure of of interferon-alphaChronic myeloid leukaemia: first targeted kinase inhibitor, approved in under 3 months source | |
| 7 May 2001 | Alemtuzumab Monoclonal antibody (anti-CD52) | Accelerated approval | US | B-cell CLL treated with alkylating agents and failed fludarabine therapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 17 May 2000 | Accelerated approval | US | For patients with CD33+ AML in first relapse 60 years of age or older and not candidates for cytotoxic chemotherapyAccelerated approval, relapsed CD33+ AML in older patients; first ADC ever approved source | |
| 23 Dec 1999 | Accelerated approval | US | To reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis patients, as an adjunct to usual careAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 11 Aug 1999 | Temozolomide Oral alkylating chemotherapy | Accelerated approval | US | Adults with refractory anaplastic astrocytomaAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 28 Jun 1999 | Pegylated liposomal doxorubicin Cytotoxic (liposomal anthracycline) | Accelerated approval | US | Metastatic ovarian carcinoma refractory to paclitaxel and platinum-based chemotherapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 1 Apr 1999 | Accelerated approval | US | Intrathecal treatment of lymphomatous meningitisAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 5 Feb 1999 | Denileukin diftitox IL-2 receptor-directed cytotoxin (fusion protein) | Accelerated approval | US | Persistent or recurrent cutaneous T-cell lymphoma expressing the CD25 component of IL-2 receptorAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 22 Oct 1998 | Irinotecan (and liposomal irinotecan) Topoisomerase I inhibitor (camptothecin prodrug) | Confirmed | US | Metastatic colon or rectal carcinoma that progressed following 5-FU therapyConfirmed: the accelerated approval of 1996 converted to traditional approval 2.4 years after it was granted. |
| 25 Sept 1998 | Approval | US | HER2+ metastatic breast cancer: first targeted antibody for a solid tumour source | |
| 22 Jun 1998 | Docetaxel Cytotoxic chemotherapy (taxane) | Confirmed | US | Locally advanced or metastatic breast carcinoma that progressed during anthracycline-based therapy or relapsed during anthracycline-based adjuvant therapyConfirmed: the accelerated approval of 1996 converted to traditional approval 2.1 years after it was granted. |
| 30 Apr 1998 | Accelerated approval | US | Metastatic breast cancer resistant to paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and further anthracycline therapy is contraindicatedAccelerated approval on a surrogate endpoint, with a confirmatory trial required. | |
| 12 Dec 1997 | Bicalutamide Oral first-generation non-steroidal antiandrogen | Confirmed | US | In combination with an LHRH analogue for advanced prostate cancerConfirmed: the accelerated approval of 1995 converted to traditional approval 2.2 years after it was granted. |
| 25 Jul 1997 | Approval | US | Letrozole approved for advanced breast cancer | |
| 14 Jun 1996 | Irinotecan (and liposomal irinotecan) Topoisomerase I inhibitor (camptothecin prodrug) | Accelerated approval | US | Metastatic colon or rectal carcinoma that progressed following 5-FU therapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 14 May 1996 | Docetaxel Cytotoxic chemotherapy (taxane) | Accelerated approval | US | Locally advanced or metastatic breast carcinoma that progressed during anthracycline-based therapy or relapsed during anthracycline-based adjuvant therapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 17 Nov 1995 | Pegylated liposomal doxorubicin Cytotoxic (liposomal anthracycline) | Accelerated approval | US | Kaposi's sarcoma in AIDS patients with disease progression on prior combination chemotherapy or who are intolerant to such therapyAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 4 Oct 1995 | Bicalutamide Oral first-generation non-steroidal antiandrogen | Accelerated approval | US | In combination with an LHRH analogue for advanced prostate cancerAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 26 May 1995 | Dexrazoxane Cardioprotectant and extravasation antidote (bisdioxopiperazine) | Accelerated approval | US | Supportive Care: Prevention of cardiomyopathy associated with doxorubicin administrationAccelerated approval on a surrogate endpoint, with a confirmatory trial required. |
| 13 Apr 1994 | Approval | US | Metastatic breast cancer source | |
| 29 Dec 1992 | Approval | US | Refractory ovarian cancer source | |
| 3 Mar 1989 | Carboplatin Cytotoxic chemotherapy (platinum) | Approval | US | Ovarian cancer source |
| 1946 | Radioactive iodine (I-131) Radiopharmaceutical (beta/gamma emitter, natural uptake) | Approval | US | First therapeutic use in thyroid cancer (Seidlin); formal approval followed |
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