OnCo regulatory events

PDUFA date: Ivonescimab (US, 2026-11-14)

2026-11-14T00:00:00Z

PDUFA target date

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Belzutifan (US, 2026-09-24)

2026-09-24T00:00:00Z

With lenvatinib, advanced renal cell carcinoma with a clear cell component

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-combination-lenvatinib-advanced-renal-cell-carcinoma-clear-cell-component

Approval: Lenvatinib (US, 2026-09-24)

2026-09-24T00:00:00Z

With belzutifan, advanced renal cell carcinoma with a clear cell component

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-combination-lenvatinib-advanced-renal-cell-carcinoma-clear-cell-component

Advisory committee: Galleri (US, 2026-09-23)

2026-09-23T00:00:00Z

FDA Molecular and Clinical Genetics Panel meeting

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Lirafugratinib (US, 2026-09-23)

2026-09-23T00:00:00Z

Previously treated unresectable, locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement (REFOCUS)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lirafugratinib-previously-treated-unresectable-locally-advanced-or-metastatic

Approval: Abemaciclib (US, 2026-09-18)

2026-09-18T00:00:00Z

With imlunestrant, for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-combination-abemaciclib-er-positive-her2-negative-esr1-mutated-advanced-or

Approval: Imlunestrant (US, 2026-09-18)

2026-09-18T00:00:00Z

With abemaciclib, for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-combination-abemaciclib-er-positive-her2-negative-esr1-mutated-advanced-or

Accelerated approval: Sevabertinib (US, 2026-09-09)

2026-09-09T00:00:00Z

FDA 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: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-locally-advanced-or-metastatic-non-squamous-non-small

Accelerated approval: Camizestrant (US, 2026-09-04)

2026-09-04T00:00:00Z

Accelerated approval (Etcamah) The confirmatory requirement was still open 0.0 years later, when the FDA's table was read.

Source: https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-new-breast-cancer-treatment

Withdrawal: Adagrasib (US, 2026-09-01)

2026-09-01T00:00:00Z

Withdrawn: the indication came off the label 2.3 years after its accelerated approval.

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-adagrasib-cetuximab-kras-g12c-mutated-colorectal-cancer

PDUFA date: 177Lu-edotreotide (US, 2026-08-28)

2026-08-28T00:00:00Z

PDUFA goal date for GEP-NET indication

Source: https://www.cancernetwork.com/view/fda-accepts-new-drug-application-for-177lu-edotreotide-in-gep-nets

Approval: Daraxonrasib (US, 2026-08-26)

2026-08-26T00:00:00Z

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: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220910Orig1s000ltr.pdf

Approval: Tislelizumab (US, 2026-08-25)

2026-08-25T00:00:00Z

FDA approves zanidatamab-hrii and tislelizumab-jsgr for HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanidatamab-hrii-and-tislelizumab-jsgr-her2-positive-gastric-gastroesophageal-junction

Approval: Zanidatamab (US, 2026-08-25)

2026-08-25T00:00:00Z

First-line HER2-positive gastric, gastro-oesophageal junction or oesophageal adenocarcinoma with tislelizumab and fluoropyrimidine-platinum chemotherapy

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanidatamab-hrii-and-tislelizumab-jsgr-her2-positive-gastric-gastroesophageal-junction

Filing: Intismeran autogene (US, 2026-08-19)

2026-08-19T00:00:00Z

Phase 3 INTerpath-001 met RFS and DMFS endpoints; filings to follow

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Daratumumab (US, 2026-08-13)

2026-08-13T00:00:00Z

FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone

Approval: Dexamethasone (US, 2026-08-13)

2026-08-13T00:00:00Z

FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone

Accelerated approval: Iberdomide (US, 2026-08-13)

2026-08-13T00:00:00Z

FDA 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: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone

Approval: Nivolumab (US, 2026-08-06)

2026-08-06T00:00:00Z

Accelerated approval of vusolimogene oderparepvec in combination with nivolumab, unresectable advanced cutaneous melanoma

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-vusolimogene-oderparepvec-wtpg-combination-nivolumab-melanoma

Accelerated approval: Vusolimogene oderparepvec (US, 2026-08-06)

2026-08-06T00:00:00Z

Accelerated 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: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Lutetium-177 vipivotide tetraxetan (US, 2026-07-31)

2026-07-31T00:00:00Z

PSMA+ metastatic hormone-sensitive prostate cancer with ARPI (PSMAddition)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Filing: Selinexor (US, 2026-07-30)

2026-07-30T00:00:00Z

XPORT-EC-042 misses primary endpoint; endometrial development deprioritised

Source: https://cancerletter.com/clinical-roundup/20260807_8a/

Complete response letter: Camrelizumab + rivoceranib (US, 2026-07-23)

2026-07-23T00:00:00Z

Third CRL, again cGMP

Source: https://www.targetedonc.com/view/fda-passes-again-on-approving-rivoceranib-plus-camrelizumab-in-hcc

Approval: Zidesamtinib (US, 2026-07-22)

2026-07-22T00:00:00Z

ROS1+ NSCLC after at least one prior ROS1 TKI (ARROS-1)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zidesamtinib-ros1-positive-non-small-cell-lung-cancer

Filing: Daraxonrasib (US, 2026-07-17)

2026-07-17T00:00:00Z

NDA 220910 received by the FDA on the RASolute 302 result

Source: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220910Orig1s000ltr.pdf

Approval: Isatuximab (US, 2026-07)

2026-07-15T00:00:00Z

Subcutaneous on-body injector

Designation: Sacituzumab tirumotecan (US, 2026-07)

2026-07-15T00:00:00Z

Commissioner's National Priority Voucher (CNPV) awarded

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Fulvestrant (US, 2026-07-14)

2026-07-14T00:00:00Z

FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locally

Approval: Gedatolisib (US, 2026-07-14)

2026-07-14T00:00:00Z

HR+/HER2- advanced breast cancer after CDK4/6 inhibitor with palbociclib and fulvestrant (VIKTORIA-1)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locally

Approval: Palbociclib (US, 2026-07-14)

2026-07-14T00:00:00Z

Gedatolisib with fulvestrant, with or without palbociclib, HR+/HER2- advanced breast cancer (VIKTORIA-1)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locally

Accelerated approval confirmed: Selpercatinib (US, 2026-07-14)

2026-07-14T00:00:00Z

Traditional approval, locally advanced or metastatic RET fusion-positive solid tumours

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive

Accelerated approval confirmed: Selpercatinib (US, 2026-07-14)

2026-07-14T00:00:00Z

Confirmed: the accelerated approval of 2024 converted to traditional approval 2.3 years after it was granted.

Approval: Enfortumab vedotin (US, 2026-07-10)

2026-07-10T00:00:00Z

Muscle-invasive bladder cancer with pembrolizumab, with or without berahyaluronidase alfa

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-or-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-enfortumab-vedotin

Approval: Pembrolizumab (US, 2026-07-10)

2026-07-10T00:00:00Z

Muscle-invasive bladder cancer with enfortumab vedotin, as pembrolizumab or pembrolizumab with berahyaluronidase alfa

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-or-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-enfortumab-vedotin

Approval: Isatuximab (US, 2026-07-09)

2026-07-09T00:00:00Z

FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-subcutaneous-injection-multiple-myeloma-indications

Approval: Allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq (US, 2026-06-30)

2026-06-30T00:00:00Z

FDA approves allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq (Tregzi, Orca Bio) on the Precision-T trial

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-allogeneic-regulatory-t-cell-based-immunotherapy-hspc-and-t-cells-vldq-use-matched

Filing: Cretostimogene grenadenorepvec (US, 2026)

2026-06-30T00:00:00Z

Rolling BLA initiated; completion expected Q4 2026

Source: https://cgoncology.com/cg-oncology-reports-first-quarter-2026-financial-results-and-provides-business-updates-2/

Designation: Fianlimab (US, 2026)

2026-06-30T00:00:00Z

First-line metastatic phase 3 missed its primary PFS endpoint (Regeneron release)

Complete response letter: Tacquell (autologous melanoma-derived tumour-infiltrating lymphocytes) (EU, 2026-06-25)

2026-06-25T00:00:00Z

CHMP negative opinion on Tacquell (autologous TIL) for melanoma; applicant Netherlands Cancer Institute

Source: https://www.ema.europa.eu/en/medicines/human/EPAR/tacquell

Approval: Palbociclib (US, 2026-06-24)

2026-06-24T00:00:00Z

Maintenance in HR+/HER2+ advanced breast cancer with anti-HER2 and endocrine therapy (PATINA)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-palbociclib-trastuzumab-or-without-pertuzumab-and-endocrine-therapy-maintenance

Approval: Pembrolizumab (US, 2026-06-24)

2026-06-24T00:00:00Z

First-line PD-L1+ TNBC with sacituzumab govitecan (ASCENT-04)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line

Approval: Pertuzumab (US, 2026-06-24)

2026-06-24T00:00:00Z

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: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-palbociclib-trastuzumab-or-without-pertuzumab-and-endocrine-therapy-maintenance

Approval: Sacituzumab govitecan (US, 2026-06-24)

2026-06-24T00:00:00Z

First-line metastatic TNBC: monotherapy (PD-1 ineligible, ASCENT-03) and with pembrolizumab (CPS ≥10, ASCENT-04)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line

Approval: Trastuzumab (US, 2026-06-24)

2026-06-24T00:00:00Z

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: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-palbociclib-trastuzumab-or-without-pertuzumab-and-endocrine-therapy-maintenance

Withdrawal: Tazemetostat (US, 2026-06-22)

2026-06-22T00:00:00Z

Withdrawn: the indication came off the label 6.4 years after its accelerated approval.

Source: https://wayback.archive-it.org/7993/20201222063544/https:/www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tazemetostat-advanced-epithelioid-sarcoma

Withdrawal: Tazemetostat (US, 2026-06-22)

2026-06-22T00:00:00Z

Withdrawn: the indication came off the label 6.0 years after its accelerated approval.

Source: https://wayback.archive-it.org/7993/20201222062826/https:/www.fda.gov/drugs/fda-granted-accelerated-approval-tazemetostat-follicular-lymphoma

Approval: Abiraterone acetate (US, 2026-06-12)

2026-06-12T00:00:00Z

Capivasertib approved for use with abiraterone and prednisone in PTEN-deficient metastatic prostate cancer (CAPItello-281); abiraterone itself was already approved

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-abiraterone-and-prednisone-pten-deficient-androgen-pathway-modulation

Approval: Belzutifan (US, 2026-06-12)

2026-06-12T00:00:00Z

Adjuvant clear-cell RCC with pembrolizumab (LITESPARK-022)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pembrolizumab-adjuvant-treatment-renal-cell-carcinoma

Approval: Capivasertib (US, 2026-06-12)

2026-06-12T00:00:00Z

PTEN-deficient metastatic prostate cancer with abiraterone (CAPItello-281)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-abiraterone-and-prednisone-pten-deficient-androgen-pathway-modulation

Approval: Pembrolizumab (US, 2026-06-12)

2026-06-12T00:00:00Z

Adjuvant RCC with belzutifan (LITESPARK-022)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pembrolizumab-adjuvant-treatment-renal-cell-carcinoma

Approval: Prednisone (US, 2026-06-12)

2026-06-12T00:00:00Z

FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-abiraterone-and-prednisone-pten-deficient-androgen-pathway-modulation

Approval: Durvalumab (US, 2026-05-28)

2026-05-28T00:00:00Z

High-risk non-muscle-invasive bladder cancer with BCG (POTOMAC)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-combination-bacillus-calmette-guerin-high-risk-non-muscle-invasive-bladder

Approval: Pivekimab sunirine (US, 2026-05-27)

2026-05-27T00:00:00Z

FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare hematologic malignancy

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pivekimab-sunirine-pvzy-blastic-plasmacytoid-dendritic-cell-neoplasm-ultra-rare

Approval: Datopotamab deruxtecan (US, 2026-05-22)

2026-05-22T00:00:00Z

First-line unresectable/metastatic TNBC, PD-1/PD-L1 inhibitor ineligible (TROPION-Breast02)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer

Label change: Afamitresgene autoleucel (US, 2026-Q2)

2026-05-15T00:00:00Z

Label extended to patients aged 12 and older

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: ArteraAI Breast (US, 2026-05)

2026-05-15T00:00:00Z

FDA clearance: first digital-pathology-based risk stratification tool for early HR+/HER2- breast cancer

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Atezolizumab (US, 2026-Q2)

2026-05-15T00:00:00Z

Adjuvant ctDNA-positive muscle-invasive bladder cancer (IMvigor011): first ctDNA-guided indication

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Label change: Signatera (US, 2026-Q2)

2026-05-15T00:00:00Z

Used to select ctDNA-positive patients in the first ctDNA-guided drug approval (IMvigor011, atezolizumab)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Trastuzumab deruxtecan (US, 2026-Q2)

2026-05-15T00:00:00Z

Early-stage HER2+ breast cancer: neoadjuvant (DESTINY-Breast11) and post-neoadjuvant residual disease (DESTINY-Breast05)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Label change: Trastuzumab emtansine (US, 2026-Q2)

2026-05-15T00:00:00Z

Displaced post-neoadjuvantly by T-DXd approval (DESTINY-Breast05)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Vepdegestrant (US, 2026-Q2)

2026-05-15T00:00:00Z

ESR1-mutated ER+/HER2- advanced breast cancer after endocrine therapy: first PROTAC approved

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Zenocutuzumab (US, 2026-Q2)

2026-05-15T00:00:00Z

NRG1-fusion cholangiocarcinoma

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Decitabine + cedazuridine (oral) (US, 2026-05-13)

2026-05-13T00:00:00Z

With venetoclax in newly diagnosed unfit AML

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-oral-combination-decitabine-and-cedazuridine-tablets-venetoclax-newly-diagnosed-acute

Accelerated approval: Sonrotoclax (US, 2026-05-13)

2026-05-13T00:00:00Z

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: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sonrotoclax-relapsed-or-refractory-mantle-cell-lymphoma

Advisory committee: Camizestrant (US, 2026-04-30)

2026-04-30T00:00:00Z

ODAC voted 6-3 against (clinical relevance of ctDNA-triggered switch)

Source: https://www.cancernetwork.com/view/fda-odac-no-camizestrant-for-hr-her2-esr1-advanced-breast-cancer

Withdrawal: Selinexor (US, 2026-04-30)

2026-04-30T00:00:00Z

Withdrawn: the indication came off the label 5.9 years after its accelerated approval.

Source: https://wayback.archive-it.org/7993/20201222062817/https:/www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selinexor-relapsedrefractory-diffuse-large-b-cell-lymphoma

Accelerated approval confirmed: Brexucabtagene autoleucel (US, 2026-04-01)

2026-04-01T00:00:00Z

Confirmed: the accelerated approval of 2020 converted to traditional approval 5.7 years after it was granted.

Accelerated approval confirmed: Nivolumab (US, 2026-03-20)

2026-03-20T00:00:00Z

Confirmed: the accelerated approval of 2016 converted to traditional approval 9.8 years after it was granted.

Accelerated approval confirmed: Nivolumab (US, 2026-03-20)

2026-03-20T00:00:00Z

Confirmed: the accelerated approval of 2017 converted to traditional approval 8.9 years after it was granted.

Approval: Nivolumab (US, 2026-03)

2026-03-15T00:00:00Z

First-line advanced classical Hodgkin lymphoma with AVD, age ≥12 (SWOG S1826)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Filing: Tafasitamab (US, 2026-03)

2026-03-15T00:00:00Z

sBLA for frontline high-risk DLBCL (frontMIND) planned H1 2026

Source: https://www.onclive.com/view/frontmind-results-tafasitamab-based-combo-yields-significant-pfs-benefit-over-r-chop-in-frontline-high-risk-dlbcl

Withdrawal: Tazemetostat (Global, 2026-03)

2026-03-15T00:00:00Z

Withdrawn over secondary haematologic malignancies

Withdrawal: Zelenectide pevedotin (US, 2026-03)

2026-03-15T00:00:00Z

Programme deprioritised after regulatory feedback on Duravelo-2 design

Source: https://www.oncologypipeline.com/apexonco/bicycle-finally-falls

Designation: Giredestrant (Global, 2026-03-09)

2026-03-09T00:00:00Z

persevERA primary endpoint not met

Source: https://www.roche.com/media/releases/med-cor-2026-03-09

Approval: Piflufolastat F-18 / Pylarify TruVu (US, 2026-03-09)

2026-03-09T00:00:00Z

Pylarify TruVu formulation

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Daratumumab (US, 2026-03-05)

2026-03-05T00:00:00Z

Teclistamab + daratumumab after ≥1 prior line

Source: https://www.jnj.com/media-center/press-releases/johnson-johnson-announces-u-s-fda-approval-of-tecvayli-plus-darzalex-faspro-for-relapsed-refractory-multiple-myeloma-offering-a-potential-new-standard-of-care-as-early-as-second-line

Accelerated approval confirmed: Teclistamab (US, 2026-03-05)

2026-03-05T00:00:00Z

Confirmed: the accelerated approval of 2022 converted to traditional approval 3.4 years after it was granted.

Filing: Izalontamab brengitecan (China, 2026-02-26)

2026-02-26T00:00:00Z

Positive interim phase 3 in pretreated TNBC (BL-B01D1-307) announced; regulatory submissions follow

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Accelerated approval: Zongertinib (US, 2026-02-26)

2026-02-26T00:00:00Z

Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 0.6 years later, when the FDA's table was read.

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-unresectable-or-metastatic-non-squamous-non-small-cell

Accelerated approval confirmed: Encorafenib (US, 2026-02-24)

2026-02-24T00:00:00Z

Confirmed: the accelerated approval of 2024 converted to traditional approval 1.2 years after it was granted.

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-encorafenib-cetuximab-and-mfolfox6-metastatic-colorectal-cancer-braf

Accelerated approval confirmed: Lisocabtagene maraleucel (US, 2026-02-20)

2026-02-20T00:00:00Z

Confirmed: the accelerated approval of 2024 converted to traditional approval 1.8 years after it was granted.

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-lisocabtagene-maraleucel-follicular-lymphoma

Approval: Acalabrutinib (US, 2026-02-19)

2026-02-19T00:00:00Z

Acalabrutinib + venetoclax fixed duration (AMPLIFY)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-venetoclax-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma

Filing: Giredestrant (US, 2026-02-19)

2026-02-19T00:00:00Z

NDA accepted (evERA, ESR1-mutant)

Source: https://www.gene.com/media/press-releases/15100/2026-02-19/fda-accepts-new-drug-application-for-gen

Filing: Anitocabtagene autoleucel (US, 2026-02)

2026-02-15T00:00:00Z

BLA accepted; PDUFA 27 December 2026

Source: https://allsci.com/news/earnings-call-insights/gileads-q126-earnings-call-anito-cel-poised-for-december-pdufa-decision-three-acquisitions-near-inflection-points/

Designation: Atirmociclib (Global, 2026-02)

2026-02-15T00:00:00Z

Positive topline phase 2 FOURLIGHT-1

Source: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-topline-phase-2-results-next

Approval: Encorafenib (US, 2026-Q1)

2026-02-15T00:00:00Z

Full approval in first-line BRAF V600E mCRC with OS benefit

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Optune / Optune Pax (TTFields) (US, 2026-Q1)

2026-02-15T00:00:00Z

Optune Pax, locally advanced pancreatic cancer with chemotherapy (PANOVA-3)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Pembrolizumab (US, 2026-Q1)

2026-02-15T00:00:00Z

Platinum-resistant PD-L1+ ovarian cancer

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Relacorilant (US, 2026-Q1)

2026-02-15T00:00:00Z

Platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer with nab-paclitaxel

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Teclistamab (US, 2026-Q1)

2026-02-15T00:00:00Z

Relapsed/refractory myeloma after ≥1 prior line, with daratumumab (MajesTEC-3)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Zongertinib (US, 2026-Q1)

2026-02-15T00:00:00Z

First-line HER2-mutant non-squamous NSCLC

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Filing: Camrelizumab + rivoceranib (US, 2026-01-30)

2026-01-30T00:00:00Z

Resubmission accepted; PDUFA 23 July 2026

Source: https://www.globenewswire.com/news-release/2026/01/30/3229623/0/en/elevar-therapeutics-announces-fda-acceptance-of-new-drug-application-resubmission-for-rivoceranib-in-combination-with-camrelizumab-as-a-first-line-systemic-treatment-for-unresectab.html

Filing: Galleri (US, 2026-01-29)

2026-01-29T00:00:00Z

Final PMA module submitted

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Filing: Epcoritamab (US, 2026-01-16)

2026-01-16T00:00:00Z

EPCORE DLBCL-1 topline: PFS met, OS (US primary endpoint) not met

Source: https://news.abbvie.com/2026-01-16-AbbVie-Announces-Topline-Results-for-Epcoritamab-DuoBody-R-CD3xCD20-from-Phase-3-EPCORE-R-DLBCL-1-Trial-in-Patients-with-Relapsed-Refractory-Diffuse-Large-B-cell-Lymphoma-DLBCL

Filing: Ivonescimab (US, 2026-01)

2026-01-15T00:00:00Z

BLA submitted by Summit for EGFR-mutant NSCLC after TKI (HARMONi)

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Accelerated approval: Mosunetuzumab (US, 2025-12-19)

2025-12-19T00:00:00Z

Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 0.7 years later, when the FDA's table was read.

Accelerated approval confirmed: Retifanlimab (US, 2025-12-17)

2025-12-17T00:00:00Z

Confirmed: the accelerated approval of 2023 converted to traditional approval 2.7 years after it was granted.

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-retifanlimab-dlwr-metastatic-or-recurrent-locally-advanced-merkel

Accelerated approval confirmed: Rucaparib (US, 2025-12-17)

2025-12-17T00:00:00Z

Confirmed: the accelerated approval of 2020 converted to traditional approval 5.6 years after it was granted.

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-retifanlimab-dlwr-metastatic-or-recurrent-locally-advanced-merkel

Filing: Disitamab vedotin (China, 2025-12)

2025-12-15T00:00:00Z

First-line urothelial cancer with toripalimab, positive phase 3

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

Approval: Tarlatamab (US, 2025-12)

2025-12-15T00:00:00Z

Full approval based on DeLLphi-304

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications