A PD-L1 blocker that became standard after chemoradiation for stage III lung cancer, and now in bladder, biliary, and gastric cancers.
PACIFIC (unresectable stage III NSCLC), ADRIATIC (limited-stage SCLC, 2024), TOPAZ-1 (biliary tract), HIMALAYA (HCC with tremelimumab), NIAGARA (perioperative muscle-invasive bladder cancer, 2025), MATTERHORN (perioperative gastric, 2025), and Q2 2026 high-risk non-muscle-invasive bladder cancer with BCG (POTOMAC). Partner of Dato-DXd in TROPION-Breast05.
Backbone ribbon from PDB 5X8M. RCSB PDB 5X8M. The ribbon widens where the chain is folded into a regular pattern and narrows where it is a loose loop.
Human IgG1 anti-PD-L1 with reduced Fc effector function. Connects to PD-L1.
1.Antibody binds PD-L1
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. HCPCS J9173.
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE TA578 · NHS England Cancer Drugs Fund list · SMC advice: durvalumab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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 chemotherapy
Urothelial carcinoma (accelerated; later withdrawn 2021) source
Unresectable stage III NSCLC after chemoradiation (PACIFIC) source
Extensive-stage SCLC with chemotherapy (CASPIAN) source
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 chemotherapy
Withdrawn: the indication came off the label 3.8 years after its accelerated approval.
Biliary tract cancer with chemotherapy (TOPAZ-1) source
HCC with tremelimumab (HIMALAYA) source
Limited-stage SCLC after chemoradiation (ADRIATIC) source
Perioperative muscle-invasive bladder cancer (NIAGARA) source
Perioperative gastric/GEJ cancer with FLOT (MATTERHORN) source
High-risk non-muscle-invasive bladder cancer with BCG (POTOMAC) source
| Region | Year | Indication |
|---|---|---|
| US | 2017 | Locally advanced or metastatic urothelial carcinoma after platinum (accelerated; indication withdrawn 2021) |
| US | 2018 | Unresectable stage III NSCLC after chemoradiation |
| US | 2022 | Locally advanced or metastatic biliary tract cancer (gallbladder cancer included) with gemcitabine and cisplatin (TOPAZ-1) · Imfinzi label section 1.3 (openFDA): https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22IMFINZI%22 |
| UK | 2024 | Locally advanced, unresectable or metastatic biliary tract cancer with gemcitabine and cisplatin; NICE TA944 recommended 10 January 2024 with a commercial arrangement · https://www.nice.org.uk/guidance/ta944 |
| US | 2026 | High-risk NMIBC with BCG |
| England (NICE) | 2022 | Locally advanced unresectable non-small-cell lung cancer with PD-L1 on 1 percent or more of cells that has not progressed after concurrent platinum-based chemoradiation · TA798, published 22 June 2022 (PACIFIC). The PD-L1 restriction and the requirement for concurrent, not sequential, chemoradiation are NICE conditions the licence does not carry. |
| England (NICE) | 2025 | Untreated extensive-stage small-cell lung cancer, with etoposide and either carboplatin or cisplatin · TA1041, published 19 February 2025, only at ECOG performance status 0 or 1 (CASPIAN). |
| England (NICE) | 2025 | Resectable non-small-cell lung cancer (4 cm or more, or node positive) without an EGFR mutation or ALK rearrangement, neoadjuvant with platinum chemotherapy then adjuvant alone · TA1030, published 15 January 2025 (AEGEAN). |
| England (NICE) | 2025 | Limited-stage small-cell lung cancer that has not progressed after platinum-based chemoradiotherapy · TA1099, published 1 October 2025 (ADRIATIC); must be funded in England within 90 days of publication. |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Pneumonitis (any cause, PACIFIC) vs 12.8% placebo; 1.1% fatal | 18.3% | - |
| Cough PACIFIC; all-grade ≥20% | - | - |
| Fatigue PACIFIC; all-grade ≥20% | - | - |
| Radiation pneumonitis PACIFIC; all-grade ≥20% | - | - |
| Upper respiratory infection PACIFIC; all-grade ≥20% | - | - |
| Dyspnoea PACIFIC; all-grade ≥20% | - | - |
| Rash PACIFIC; all-grade ≥20% | - | - |
Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
Read for the class this product belongs to (immune checkpoint inhibitors) unless the answer names the product. Population figures from the cohorts named, not a prediction for one person. Blank where no source gives a recovery figure.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | astrazeneca-us.com/medicines/access-360 |
| United Kingdom | NICE: recommended after chemoradiation in stage III NSCLC (TA798), biliary tract cancer, limited-stage SCLC, perioperative bladder and gastric cancer | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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The tail of long survivors is the case for chemo-immunotherapy in gallbladder cancer, where the median gain is under two months. Who lands in that tail is still unknown; no biomarker in the trial predicts it.
Chemoembolisation combined with durvalumab and bevacizumab is a new option for intermediate-stage hepatocellular carcinoma where approved, though overall survival benefit is not yet shown.
Perioperative durvalumab with FLOT is a new standard for resectable gastric and junctional adenocarcinoma irrespective of PD-L1 expression.
Patients with limited-stage small-cell lung cancer who complete chemoradiotherapy without progression should now be offered up to two years of durvalumab consolidation, which extends life by almost two years on average. This is the first survival improvement for limited-stage disease since twice-daily radiotherapy and prophylactic cranial irradiation, and small-cell lung cancer is no longer a disease where immunotherapy gives only marginal gains.
Durvalumab-based chemo-immunotherapy is a third first-line option with RUBY and NRG-GY018, and durvalumab plus olaparib maintenance is approved for mismatch repair-proficient disease in some regions.
Patients fit enough for cisplatin whose bladder cancer has invaded the muscle wall should now be offered durvalumab with their pre-operative chemotherapy and for about a year after surgery, which improves the chance of cure without compromising the operation. The trial cannot say whether the adjuvant phase is necessary, or how to treat cisplatin-ineligible patients, for whom other trials are ongoing.
Stage III lung cancer is now treated by genotype as well as by stage: an EGFR mutation moves a patient from durvalumab consolidation to osimertinib consolidation. It is also the strongest hazard ratio in the lung cancer literature, which is a reason to read the overall survival data carefully when they arrive.
Perioperative immunotherapy is now standard for resectable lung cancer without a targetable driver. The updated overall survival hazard ratio of 0.89, with a confidence interval crossing one, is the honest state of the evidence on whether it cures more people.
Query for this drug: (TITLE:"Durvalumab" OR ABSTRACT:"Durvalumab" OR TITLE:"Imfinzi" OR ABSTRACT:"Imfinzi") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Durvalumab, not a curated reading list.
Shares A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02), ABC-12, AK112 Combined With Chemotherapy Versus Durvalumab Combined With Chemotherapy in Advanced Biliary Tract Cancer, Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs).
Shares Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer, Immunotherapy Combined With Y-90 SIRT Therapy in Advanced Stage Intrahepatic Biliary Tract Cancer (BTC), A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement, ABC-12.
Shares Study of RP2 in Combination With Second-line Therapy in Patients With Locally Advanced or Metastatic HCC, Caution: bevacizumab-based regimens with untreated varices, Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer, Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL .
Shares CALLA, Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC, Study of AZD2811 + Durvalumab in ES-SCLC, AK112 Combined With Chemotherapy Versus Durvalumab Combined With Chemotherapy in Advanced Biliary Tract Cancer.
Shares Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours, AK112 Combined With Chemotherapy Versus Durvalumab Combined With Chemotherapy in Advanced Biliary Tract Cancer, Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs), Gemcitabine Hydrochloride, Cisplatin, Nab-Paclitaxel, and Durvalumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer.
Shares A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer, A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC), IPH5201 and Durvalumab in Patients With Resectable Non-Small Cell Lung Cancer (MATISSE), Study of AZD2811 + Durvalumab in ES-SCLC.
Shares Study of Neoadjuvant Olaparib Monotherapy and Olaparib and Durvalumab Combination in HER2 Negative BRCAm Breast Cancer, WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC, A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU), Maintenance Durvalumab (MEDI4736) and Olaparib (AZD2281) After Standard 1st Line Treatment (Carboplatin/Cisplatin, Etoposide, Durvalumab) in HRD Positive Extens.
Shares AK112 Combined With Chemotherapy Versus Durvalumab Combined With Chemotherapy in Advanced Biliary Tract Cancer, Efficacy and Safety of CRT, Durvalumab and Surgery for SST, Gemcitabine Hydrochloride, Cisplatin, Nab-Paclitaxel, and Durvalumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer, CTX-009 With Gemcitabine, Cisplatin, and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Biliary Tract Cancers.