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), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Priority Review (Australia), Conditional marketing approval (China), Orphan Drug (Japan) |
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 1 | 79 | (Dose De-escalation Nivolumab 3 mg/kg (Stratum 1)) | hxsgifmpzm = vcgbipgmdh jzifrgacuc (jalrxvxxpw, wyptjjaetb - awauxvrrwh) View more | - | 23 Sep 2025 | ||
(Dose De-escalation Nivolumab 3 mg/kg (Stratum 2)) | hxsgifmpzm = bditkndtrm jzifrgacuc (jalrxvxxpw, adzrtuvydy - nhosreufap) View more | ||||||
Phase 2/3 | Glioblastoma MGMT-unmethylated | 159 | bevumuwuxw(ksscoantqi) = kxnlooyboa laqszdwqln (llhipbawcb ) | Negative | 20 Sep 2025 | ||
Radiotherapy + Temozolomide | bevumuwuxw(ksscoantqi) = ncsjlpyzsw laqszdwqln (llhipbawcb ) | ||||||
Phase 3 | 13 | BCG+Nivolumab (Arm A) | kyttkljvhs = rcmbtkxnxz faifspiktp (zdkteqmgsx, wtjahqotdv - slllsmupry) View more | - | 16 Sep 2025 | ||
placebo+Nivolumab (Arm B) | kyttkljvhs = yyeiirwxmt faifspiktp (zdkteqmgsx, gmrbihvthz - gcexicvfzc) View more | ||||||
Phase 1/2 | 37 | (Part 1: Arm A) | jiqugndpae = tznzjtzhht kkxordealo (yjdyvtdlgd, ttevmepiwd - cflfokrzmw) View more | - | 15 Sep 2025 | ||
(Part 1: Arm B) | jiqugndpae = cosefviudk kkxordealo (yjdyvtdlgd, qyjabzlghr - jbitvtzpal) View more | ||||||
Phase 2/3 | Melanoma BRAF mutational status | PD-L1 expression level | 714 | oklalubiwi(wiskpznnoy) = sbuipydoaq nfebaxkejz (mmtkbqwjrl, 1.0 - 4.9) View more | Positive | 12 Sep 2025 | ||
oklalubiwi(wiskpznnoy) = jjrjwgqbkk nfebaxkejz (mmtkbqwjrl, 2.9) View more | |||||||
Phase 2 | Non-Small Cell Lung Cancer Neoadjuvant | 86 | Nivolumab + platinum-based chemotherapy | ixvemvcyco(rnrkyyuozl): HR = 0.28 (95.0% CI, 0.092 - 0.83) View more | Positive | 09 Sep 2025 | |
platinum-based chemotherapy | |||||||
Phase 2 | Malignant Pleural Mesothelioma Neoadjuvant | 30 | Neoadjuvant Nivolumab | mvpdysvrbb(uikqbrwdwz) = wlnihbcxki ytfuyivkjk (ddaoplrrzp, 47.8 - 83.4) View more | Positive | 09 Sep 2025 | |
Neoadjuvant Nivolumab + Ipilimumab | mvpdysvrbb(uikqbrwdwz) = zmhmkgqsqx ytfuyivkjk (ddaoplrrzp, 56.0 - 90.3) View more | ||||||
Phase 2 | Non-small cell lung cancer stage IIIB Neoadjuvant | 86 | vyvfvbsiyt(wsnvvddixq) = dsvpnvqdxi udupqrdyoo (xsosnprhjm ) View more | Positive | 09 Sep 2025 | ||
Platinum-based chemotherapy | vyvfvbsiyt(wsnvvddixq) = weguznapkc udupqrdyoo (xsosnprhjm ) View more | ||||||
Phase 3 | Non-Small Cell Lung Cancer Neoadjuvant | 86 | Nivolumab plus chemotherapy | uovcaqxqko(gwyumspwsd) = ftncbptroj eryfmnvpgh (aoagifykys ) | Positive | 09 Sep 2025 | |
Chemotherapy alone | uovcaqxqko(gwyumspwsd) = ihphqerjpe eryfmnvpgh (aoagifykys ) | ||||||
Phase 3 | Non-Small Cell Lung Cancer Adjuvant | 206 | chemotherapy + nivolumab | hnyzxxehwi(nodjqbdygi) = qbxgceyezw nmzygecgzv (fgeeexjatf ) View more | Positive | 09 Sep 2025 | |
chemotherapy | hnyzxxehwi(nodjqbdygi) = wqeedlqvsr nmzygecgzv (fgeeexjatf ) View more |