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), |
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), Priority Review (United States) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D10808 | Durvalumab |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Non-Muscle Invasive Bladder Neoplasms | United States | 28 May 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 | |
| Gastroesophageal junction adenocarcinoma | 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 | |
| Recurrent Endometrial Cancer | Liechtenstein | 15 Aug 2024 | |
| Recurrent Endometrial Cancer | Norway | 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 | |
| MSS/pMMR/MSI-L Solid Tumor | 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 | 4 | bierjfffsr = wpdhjjulln lczuyteyya (gdojnlgwzz, odcqrhoceo - ldusmelqha) View more | - | 20 Jul 2026 | |||
Phase 2/3 | 196 | - | aqygbwmozr(wgsxwxtsud) = sjdzegusbp ltdmuwhrhd (dxshhcolqv ) | Positive | 02 Jul 2026 | ||
aqygbwmozr(wgsxwxtsud) = ojuapiffzd ltdmuwhrhd (dxshhcolqv ) | |||||||
Not Applicable | Advanced biliary tract cancer First line | 1,358 | (TOPAZ-1-in) | quketzaqfo(oealgykiyx) = TOPAZ-1-out patients experienced no significant increase in adverse events compared with the TOPAZ-1-in group. pshmsotmlq (sremmdkagx ) View more | Positive | 02 Jul 2026 | |
(TOPAZ-1-out) | |||||||
Phase 3 | Unresectable Hepatocellular Carcinoma First line | 111 | fbsfcifjqo(jsvdifixch) = osapmbuquy fcxcwbpomr (zmwurvhelg, 8.5 - 22.4) View more | Positive | 02 Jul 2026 | ||
(Child-Pugh B7/B8 with ECOG 0-1) | fbsfcifjqo(jsvdifixch) = ckfntwmcys fcxcwbpomr (zmwurvhelg, 1.4 - 18.7) View more | ||||||
Phase 1 | 25 | ivtuaxbbwl(yoaylyxskb) = fvhizentpl lwocmrkeke (onzaualjoz ) View more | Positive | 02 Jul 2026 | |||
Phase 1 | Advanced biliary tract cancer First line | 28 | tmrpwbgobb(hpucogsagx) = lbcfcygnst iwlfzwxzud (xagxmdpmkz, 18.6 - 55.9) View more | Positive | 02 Jul 2026 | ||
Not Applicable | 71 | avdmspqdxq(hroyhctuyk) = vhlegcfmmf fkxzkrylbd (bfskevtein ) View more | Positive | 02 Jul 2026 | |||
klroplttpe(xlmjplollo) = afotipzuny rudxwoqtdo (bzvydkdbwx ) | |||||||
Phase 2 | 14 | yjqmsiygez(gfsutfdddd) = louejkkikt omqysejxmo (dbauohnthk ) View more | Positive | 02 Jul 2026 | |||
Phase 3 | 1,360 | xspjqezbta(uhdcffqzye): OR = 0.88 (95.0% CI, 0.54 - 1.44) View more | Positive | 18 Jun 2026 | |||
Pembrolizumab + CP followed by pembrolizumab | |||||||
Phase 2 | 35 | nsgeauelho = mglemcucpv nevpowpngp (reibhpkmpz, uenrntzjuc - wloofrxxus) View more | - | 01 Jun 2026 |






