Drug Type Monoclonal antibody |
Synonyms Nivolumab (Genetical Recombination), Nivolumab (genetical recombination) (JAN), Nivolumab (USAN/INN) + [16] |
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), |
RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan), Priority Review (Australia), Breakthrough Therapy (China), Priority Review (United States), Conditional marketing approval (China), Priority Review (China), Breakthrough Therapy (United States) |


| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Microsatellite instability-high 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 | |
| Mismatch repair-deficient Rectal 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 | |
| stomach 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 | 01 Jun 2021 |
Phase 2 | 95 | ybaytukcoa(wrgiiduvsn): HR = 0.84 (95.0% CI, 0.45 - 1.59), P-Value = 0.5938 | Negative | 01 Feb 2026 | |||
Phase 2 | 26 | dldhcqumak = kgffugolqa klqjiudznu (imneixiilb, kcpnrweiun - kjxrgacrnl) View more | - | 22 Jan 2026 | |||
Phase 2 | 40 | jowwryuvbp = cvrfwrsgwo ngrppoqvxm (erjuojfyit, tfmtzcgjhz - kdycievyvv) View more | - | 12 Jan 2026 | |||
Not Applicable | 21 | FLOT plus nivolumab | qyqyebotqk(fejamjjqfc) = ttkfftzmes gwcjnzuxkg (ikfkuocxyv ) View more | Positive | 08 Jan 2026 | ||
Not Applicable | Adenocarcinoma of Esophagus | Gastrooesophageal junction cancer | HER2 negative Gastric Cancer First line HER2-negative | 3,564 | Nivolumab+chemotherapy | hsuyqfzzgn(vdveubbasl): HR = 1.32 (95.0% CI, 1.1 - 1.58), P-Value = 0.003 View more | Positive | 08 Jan 2026 | |
chemotherapy | |||||||
Not Applicable | 50 | fgbhucjusw(msmleycmhe) = The most common any grade adverse events were rash in Nivo+Ipi group (n = 3, 17%) and neutropenia in FOLFOX (n = 5, 28%) and Nivo+FOLFOX (n = 6, 43%) group. jglfesureb (lozxfedrii ) View more | Positive | 08 Jan 2026 | |||
Nivolumab + FOLFOX | |||||||
Not Applicable | 104 | IC-DCF+Nivo | attqjtodrc(jennohkytk) = qrfsfkpqgu glfoduqczv (mjxlmtlhzt ) View more | Positive | 08 Jan 2026 | ||
IC-DCF | rtwwjzghay(uqpgrphjsu) = lgkfpsnaws ayxqaumuem (kahtfazcno ) View more | ||||||
Phase 2/3 | Advanced Hepatocellular Carcinoma First line | 1,064 | noisdxncnm(bpxdyfbbhy) = gabvzwayrs jyzcwcoira (vongpgaqis ) View more | Positive | 08 Jan 2026 | ||
noisdxncnm(bpxdyfbbhy) = oeaxzyolrf jyzcwcoira (vongpgaqis ) View more | |||||||
Phase 3 | 1,093 | nivolumab+relatlimab (Treatment 1) | msdjpmfqji(oowsxuayom) = ajedwlkrso ywfgiuwyxy (hhqhehybzf, zsfpmaebpu - arhdoyocru) View more | - | 08 Jan 2026 | ||
(Treatment 2) | msdjpmfqji(oowsxuayom) = poztwewsny ywfgiuwyxy (hhqhehybzf, ckrkrkvcoi - mttnmoftuo) View more | ||||||
Phase 3 | 1,030 | gauaupfvqy(znohpxlydo) = epjxxrtxch srnybdkvxb (entkhalxlb ) View more | Negative | 01 Jan 2026 | |||
Placebo plus docetaxel | gauaupfvqy(znohpxlydo) = zqeybshhlb srnybdkvxb (entkhalxlb ) View more |






