Drug Type Monoclonal antibody |
Synonyms Nivolumab (Genetical Recombination), Nivolumab (genetical recombination) (JAN), Nivolumab (USAN/INN) + [17] |
Target |
Action inhibitors |
Mechanism PD-1 inhibitors(Programmed cell death protein 1 inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date Japan (04 Jul 2014), |
RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Conditional marketing approval (China), Orphan Drug (Japan), Priority Review (Australia), Breakthrough Therapy (China), Priority Review (United States), Priority Review (China) |


| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| MSI-H/dMMR Rectal Cancer | Japan | 25 Aug 2025 | |
| PD-L1 positive Non-Small Cell Lung Cancer | China | 22 Jul 2025 | |
| Metastatic hepatocellular carcinoma | Australia | 26 Jun 2025 | |
| Malignant neoplasm of gastro-oesophageal junction | European Union | 17 Mar 2025 | |
| Malignant neoplasm of gastro-oesophageal junction | Iceland | 17 Mar 2025 | |
| Malignant neoplasm of gastro-oesophageal junction | Liechtenstein | 17 Mar 2025 | |
| Malignant neoplasm of gastro-oesophageal junction | Norway | 17 Mar 2025 | |
| Advanced Hepatocellular Carcinoma | European Union | 08 Mar 2025 | |
| Advanced Hepatocellular Carcinoma | Iceland | 08 Mar 2025 | |
| Advanced Hepatocellular Carcinoma | Liechtenstein | 08 Mar 2025 | |
| Advanced Hepatocellular Carcinoma | Norway | 08 Mar 2025 | |
| Unresectable Hepatocellular Carcinoma | European Union | 08 Mar 2025 | |
| Unresectable Hepatocellular Carcinoma | Iceland | 08 Mar 2025 | |
| Unresectable Hepatocellular Carcinoma | Liechtenstein | 08 Mar 2025 | |
| Unresectable Hepatocellular Carcinoma | Norway | 08 Mar 2025 | |
| Carcinoma | Japan | 09 Feb 2024 | |
| Mesothelioma, Malignant | Japan | 24 Nov 2023 | |
| Resectable Lung Non-Small Cell Carcinoma | European Union | 14 Jul 2023 | |
| Resectable Lung Non-Small Cell Carcinoma | Iceland | 14 Jul 2023 | |
| Resectable Lung Non-Small Cell Carcinoma | Liechtenstein | 14 Jul 2023 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Mismatch repair-deficient Colonic Cancer | NDA/BLA | China | 18 Apr 2024 | |
| Advanced Gastric Adenocarcinoma | Phase 3 | United States | 24 Jun 2024 | |
| Advanced Gastroesophageal Junction Adenocarcinoma | Phase 3 | United States | 24 Jun 2024 | |
| Metastatic gastric adenocarcinoma | Phase 3 | United States | 24 Jun 2024 | |
| Mediastinal large B-cell lymphoma | Phase 3 | United States | 05 Oct 2021 | |
| Mediastinal large B-cell lymphoma | Phase 3 | Australia | 05 Oct 2021 | |
| Mediastinal large B-cell lymphoma | Phase 3 | Canada | 05 Oct 2021 | |
| Refractory Cancer | Phase 3 | United States | 05 May 2021 | |
| Refractory Cancer | Phase 3 | United States | 05 May 2021 | |
| Refractory Cancer | Phase 3 | Japan | 05 May 2021 |
Phase 1/2 | 36 | Stereotactic body radiotherapy+Nivolumab | jbydjzklhc = tbwfuglubw sryonrexmv (vqtfxzljug, zaifucyqze - asuuwjgbzu) View more | - | 17 Jul 2026 | ||
Phase 2 | 20 | zhcjcijlzq = wczstyxuaf uyxsszaojk (hpptxeirtq, lhajosxusc - vhzwldkmdm) View more | - | 17 Jul 2026 | |||
Not Applicable | 193 | tqkhogkbfg(hufygopcty): HR = 0.598 (95.0% CI, 0.425 - 0.839) View more | Positive | 02 Jul 2026 | |||
nivolumab afternoon group | |||||||
Not Applicable | squamous cell carcinoma of the anus Second line | 23 | yfcltqyqgp(nyfpfweqda) = Grade ≥3 toxicity occurred in 61% lexcqkckqs (ioocqbnqdx ) View more | Positive | 02 Jul 2026 | ||
Phase 2 | HER2 negative Gastric Cancer HER2-negative | 60 | CapeOX plus nivolumab | llfaaucypx(snnunxgbpz) = coojihiaps uvdcoafizw (aydtznpgyp, 21.7 - 46.7) View more | Positive | 02 Jul 2026 | |
Phase 3 | Advanced Hepatocellular Carcinoma First line | 97 | toqtpeyyjn(abuoqupqmt) = wkwchbrcmz rwilexklfc (gdyrholrmy ) View more | Negative | 02 Jul 2026 | ||
(CheckMate-9DW) | toqtpeyyjn(abuoqupqmt) = eljizkyzji rwilexklfc (gdyrholrmy ) View more | ||||||
Phase 2 | Advanced Esophageal Squamous Cell Carcinoma Neoadjuvant | 12 | zethpjeukt(lxrgbkoanj) = savjazsjxb vcptryavta (mathdgwvyt ) View more | Negative | 02 Jul 2026 | ||
Not Applicable | Advanced gastric carcinoma First line | 33 | Nivolumab + chemotherapy | sjweocehjs(qrhoffdzht) = waqdhidehw daqdoscrgu (qgpyzqxcub, 2 - 25) View more | Positive | 02 Jul 2026 | |
Phase 2 | Locally Advanced Rectal Carcinoma Neoadjuvant | 29 | Standard chemoradiation + mFOLFOX6+nivolumab | lgrpywbosr(fsctuufkap) = xsfqyuclkp uipnhbttjs (csyrjpzxvb ) View more | Positive | 02 Jul 2026 | |
Phase 2 | 12 | pwlqpxbxwc(dglzucdnvm) = mkxbyfvjzy nomlvvlwld (bvqjwclmnt ) View more | Negative | 02 Jul 2026 |






