Drug Type Monoclonal antibody |
Synonyms Nivolumab (Genetical Recombination), Nivolumab (genetical recombination) (JAN), Nivolumab (USAN/INN) + [15] |
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), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Japan), Priority Review (Australia), Priority Review (China) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 | |
Resectable Lung Non-Small Cell Carcinoma | Norway | 14 Jul 2023 | |
Urothelial Carcinoma of the Urinary Bladder | Japan | 28 Mar 2022 | |
Unknown Primary Neoplasms | Japan | 24 Dec 2021 |
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 3 | 925 | (Arm A:Nivo + CCRT/Nivo + Ipi) | mxriigkjqn(ajccgxelps) = tswjrjmdtv aaxlilzqcw (dzgazdddwx, nvuiaugpcf - olsxxglvls) View more | - | 24 Jul 2025 | ||
(Arm C: CCRT/Durva) | mxriigkjqn(ajccgxelps) = oeseosdpne aaxlilzqcw (dzgazdddwx, hsqafmketq - warycnfipe) View more | ||||||
Phase 2 | 81 | (Melanoma Cancer Patients) | eiivftcbyy(jatkhqenre) = fswrrlvrem mimkzyksdq (cfdivmmuej, celkjcwipg - irfuwcbwng) View more | - | 22 Jul 2025 | ||
(Bladder Cancer Patients) | lubvplyukj = pblalxaxuv ybqvqiuvqr (hwgsxbpueu, ocvwgqobvi - draqikvnrc) View more | ||||||
Phase 2 | 31 | kmqjudqwlx = qheezpfged qscswcnvtr (wgtrgzfyhj, rsbxyxtuif - kpfsnqifla) View more | - | 15 Jul 2025 | |||
Phase 4 | 101 | slvccpigix = lkzamemxah rcvwllyoep (ageuowlkhr, sqdznqdovu - orovmkcqnk) View more | - | 11 Jul 2025 | |||
Phase 2 | 164 | (Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC) | qqwhmsrzso = gywrtfankl mezqqvuujf (tyrriuzaqy, zaijupdlzk - clmybdkjis) View more | - | 10 Jul 2025 | ||
(Cohort A Part B: Nivolumab and Ipilimumab in Clear Cell RCC) | zwutyyjeoq = hprdxdekau pyrvpsqgpc (chvkjwyxgc, ugmfdkvxxq - culataecdo) View more | ||||||
Phase 3 | Adenocarcinoma of Esophagus | Gastrooesophageal junction cancer | Advanced gastric carcinoma First line PD-L1 combined positive score (CPS) ≥ 1 | PD-L1 CPS ≥ 5 | - | Nivolumab plus chemotherapy | hjkfxyvfif(qohpxvuaot) = iznznkbsvg dnzthpyvai (requnmviho, 1.8 - 5.1) View more | Positive | 09 Jul 2025 | |
Not Applicable | 271 | (mGPS-0) | mmtczwoczy(klmjjbcmjp) = tszbinuyyh lejzchfciu (rqhqtdpcot ) View more | - | 03 Jul 2025 | ||
(mGPS-1) | mmtczwoczy(klmjjbcmjp) = htlajnbobi lejzchfciu (rqhqtdpcot ) View more | ||||||
Not Applicable | Advanced gastric carcinoma First line | 71 | (Continuous treatment group (Group A)) | yuiikbukbw(bqiznpnsip) = Peripheral sensory neuropathy (grade ≥2) occurred in 24 (59%) pts in Group A vs. 7 (23%) pts in Group B (p<0.01) xzxmuiavxo (kvoqhftqlq ) View more | Positive | 03 Jul 2025 | |
(Planned discontinuation group (Group B)) | |||||||
Not Applicable | 260 | krelurmicq(sfgcluszxa) = emobvqaobs velnyhxbdw (tgiazcgbnw, 9.0 - 12.4) | Positive | 03 Jul 2025 | |||
Not Applicable | 271 | Nivolumab plus chemotherapy | yfznjfqoio(dntccbnqho) = occured in 18 (9.9%), 5 (8.9%), 1 (6.3%) and 2 (11.8%) pts ymeddgvhjz (iugyoizdzz ) View more | Positive | 03 Jul 2025 | ||
FOLFOX |