Drug Type Monoclonal antibody |
Synonyms Durvalumab (Genetical Recombination), Durvalumab (genetical recombination) (JAN), Durvalumab (USAN/INN) + [10] |
Target |
Action inhibitors |
Mechanism PDL1 inhibitors(Programmed death-ligand 1 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (01 May 2017), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D10808 | Durvalumab |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Gastroesophageal junction adenocarcinoma | European Union | 16 Mar 2026 | |
| Gastroesophageal junction adenocarcinoma | Iceland | 16 Mar 2026 | |
| Gastroesophageal junction adenocarcinoma | Liechtenstein | 16 Mar 2026 | |
| Gastroesophageal junction adenocarcinoma | Norway | 16 Mar 2026 | |
| Stomach Cancer | European Union | 16 Mar 2026 | |
| Stomach Cancer | Iceland | 16 Mar 2026 | |
| Stomach Cancer | Liechtenstein | 16 Mar 2026 | |
| Stomach Cancer | Norway | 16 Mar 2026 | |
| Early gastric cancer | United States | 25 Nov 2025 | |
| Gastrooesophageal junction cancer | United States | 25 Nov 2025 | |
| Locally Advanced Gastric Carcinoma | United States | 25 Nov 2025 | |
| Unresectable Lung Non-Small Cell Carcinoma | China | 18 Nov 2025 | |
| Muscle Invasive Bladder Carcinoma | United States | 28 Mar 2025 | |
| Uterine Neoplasms | Japan | 22 Nov 2024 | |
| Advanced Endometrial Carcinoma | European Union | 15 Aug 2024 | |
| Advanced Endometrial Carcinoma | Iceland | 15 Aug 2024 | |
| Advanced Endometrial Carcinoma | Liechtenstein | 15 Aug 2024 | |
| Advanced Endometrial Carcinoma | Norway | 15 Aug 2024 | |
| Recurrent Endometrial Cancer | European Union | 15 Aug 2024 | |
| Recurrent Endometrial Cancer | Iceland | 15 Aug 2024 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| ALK positive Non-Small Cell Lung Cancer | NDA/BLA | China | 21 Feb 2025 | |
| EGFR-mutated non-small Cell Lung Cancer | NDA/BLA | China | 21 Feb 2025 | |
| Ovarian Epithelial Carcinoma | NDA/BLA | China | 16 Aug 2024 | |
| pMMR/MSS Locally Advanced Colon Cancer | Phase 3 | Spain | 30 Dec 2024 | |
| PD-L1 positive Triple Negative Breast Cancer | Phase 3 | United States | 23 Nov 2023 | |
| PD-L1 positive Triple Negative Breast Cancer | Phase 3 | China | 23 Nov 2023 | |
| PD-L1 positive Triple Negative Breast Cancer | Phase 3 | Japan | 23 Nov 2023 | |
| PD-L1 positive Triple Negative Breast Cancer | Phase 3 | Argentina | 23 Nov 2023 | |
| PD-L1 positive Triple Negative Breast Cancer | Phase 3 | Australia | 23 Nov 2023 | |
| PD-L1 positive Triple Negative Breast Cancer | Phase 3 | Brazil | 23 Nov 2023 |
Phase 2 | 8 | Neoadjuvant DurGAP therapy (TRG1) | lluoiwcrfm(dcgzvqsxlb) = nbxbsjadol ndxnuvcmcq (imuvvtyfka ) View more | Positive | 22 Apr 2026 | ||
Phase 2 | Non-Small Cell Lung Cancer Neoadjuvant | 30 | wxrzodjrgc(cxexhxprkt) = wxrvoatogn vrvimajhkn (kdufgwgxlx ) View more | Positive | 22 Apr 2026 | ||
Phase 2 | Biliary Tract Neoplasms Neoadjuvant | 45 | Durvalumab plus Gemcitabine-Cisplatin (D+GP) | oqtigmvfuf(eonsarkgmn) = osnfyoiowp ewbysbljny (moirjlkzmx ) View more | Positive | 21 Apr 2026 | |
Gemcitabine-Cisplatin (GP) | oqtigmvfuf(eonsarkgmn) = dcpkhakjzz ewbysbljny (moirjlkzmx ) View more | ||||||
Phase 2 | Hepatocellular Carcinoma First line | 30 | (Hepatocellular Carcinoma + Child-Pugh B cirrhosis) | kgyklqhmkh(bulaefqdnt) = dghazquise bmqmvpmgrm (cdilasostp ) View more | Positive | 21 Apr 2026 | |
Phase 2 | HER2 Positive Breast Cancer ER-negative | PR-negative | HER2-Enriched | 37 | gdidzwawtf(usvffvkzno) = swirctbhis gfhifqrmcc (fxsuyphbge ) | Positive | 21 Apr 2026 | ||
Phase 2/3 | Bladder Cancer First line | 200 | svojwngmgn(xieoaobspq): HR = 1.92 (95.0% CI, 1.63 - 2.25) View more | Negative | 21 Apr 2026 | ||
chemotherapy | |||||||
Phase 3 | Extensive stage Small Cell Lung Cancer Maintenance | 452 | lcavxwdeez(zniijiqidp) = goyqtvarov ssyqubtcta (bwqlzafkuc ) View more | Positive | 20 Apr 2026 | ||
lcavxwdeez(zniijiqidp) = ssfuvrwlnr ssyqubtcta (bwqlzafkuc ) View more | |||||||
Phase 2 | Neoplasm Metastasis MET | PD-L1 | tumor mutational burden (TMB) | 41 | dvnxcemawp(xoyytsozsd) = xmtqhnusri hernftlciv (upqdsqxnno, 7.3 - 30.7) View more | Positive | 20 Apr 2026 | ||
(MET-driven patients) | dvnxcemawp(xoyytsozsd) = jozcixtotx hernftlciv (upqdsqxnno, 9.3 - 37.4) View more | ||||||
Phase 2 | 51 | sfnwiuvgjv = dazdfflcyc juiamkwckf (gwrrearfvy, buhuofstvj - yfsfwaixzo) View more | - | 20 Apr 2026 | |||
Phase 3 | Malignant Pleural Mesothelioma First line | 173 | bsfbglnwjw(zruplitvck) = ORR among patients with PM expressing PD-L1 ≥1% vs <1% was 65% (31/48) vs 49% (45/92; Pearson’s chi-squared p=0.077) amsahvrjpn (ujpvjzddte ) View more | Positive | 19 Apr 2026 | ||
Chemotherapy |






