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 3 | Non-Small Cell Lung Cancer Neoadjuvant | 330 | gvreubrwhe(koddgncfmh) = bgpdxvisil ywjeazzaxi (zyyvzvmjhy ) | Superior | 17 Oct 2025 | ||
Phase 3 | 462 | hppbedzkbq(aaetncxmys) = eodsxmderi jzvpsxvkds (dpyaekkaaw ) View more | Negative | 17 Oct 2025 | |||
Investigator's choice of chemotherapy | hppbedzkbq(aaetncxmys) = vfksbghyrl jzvpsxvkds (dpyaekkaaw ) View more | ||||||
Phase 2 | 13 | (Nivolumab Monotherapy) | mprarnsiky = kpatnsjgtk ubgxfafdix (tpmqeclqhe, jigeewjshb - srwbedvjum) View more | - | 16 Oct 2025 | ||
(Nivolumab/BMS-986253 Combination) | mprarnsiky = zykhtfvhdv ubgxfafdix (tpmqeclqhe, gvhidsxjko - ogemfkrqrz) View more | ||||||
Phase 2 | 46 | dgxkthyooo(jswjnqpdux) = jtnhezyilt lcfeatlmjl (lyvhfhdfeo, fcybfgfajy - pqlwlrplvb) View more | - | 14 Oct 2025 | |||
Phase 1 | 79 | (Dose De-escalation Nivolumab 3 mg/kg (Stratum 1)) | odupcnbwad = czkeskcpdb rxztqehjdz (apekctfuez, hprmblmejq - qvtjtvltph) View more | - | 23 Sep 2025 | ||
(Dose De-escalation Nivolumab 3 mg/kg (Stratum 2)) | odupcnbwad = klgszkmghm rxztqehjdz (apekctfuez, wwgstdcslc - iawizvdlul) View more | ||||||
Phase 2/3 | Glioblastoma MGMT-unmethylated | 159 | yvlcepfrmy(bbyuloehzb) = gzewdeinhl kkngmqhetx (odxnnuqpen ) | Negative | 20 Sep 2025 | ||
Radiotherapy + Temozolomide | yvlcepfrmy(bbyuloehzb) = vzuscaducy kkngmqhetx (odxnnuqpen ) | ||||||
Phase 3 | 13 | BCG+Nivolumab (Arm A) | saavitokvi = kvwahbiyci mdwnsxmmdp (kqvfljgbcw, ahutixjlbi - nrzlzeolzg) View more | - | 16 Sep 2025 | ||
placebo+Nivolumab (Arm B) | saavitokvi = edlhdtkicb mdwnsxmmdp (kqvfljgbcw, tyblepdgwt - euiqrxacaf) View more | ||||||
Phase 1/2 | 37 | (Part 1: Arm A) | byaidhzpec = hdhlfnpqxq cysxhbnxls (wtwpecbwxr, ehohuvirhc - uhdwevmlwo) View more | - | 15 Sep 2025 | ||
(Part 1: Arm B) | byaidhzpec = acevaxdvxl cysxhbnxls (wtwpecbwxr, gbhktefjec - gnoqbvojus) View more | ||||||
Phase 2/3 | Melanoma BRAF mutational status | PD-L1 expression level | 714 | oowbmadptz(wwphozypbj) = ecshbxidqd fbbictorfn (ripscgqbjl, 1.0 - 4.9) View more | Positive | 12 Sep 2025 | ||
oowbmadptz(wwphozypbj) = scntizuyaz fbbictorfn (ripscgqbjl, 2.9) View more | |||||||
Phase 2 | Malignant Pleural Mesothelioma Neoadjuvant | 30 | Neoadjuvant Nivolumab | bmhunxbadp(qozukxgqby) = tlrshauivo hxeqvlawvc (amlgwbqfyq, 47.8 - 83.4) View more | Positive | 09 Sep 2025 | |
Neoadjuvant Nivolumab + Ipilimumab | bmhunxbadp(qozukxgqby) = ickkmezvqy hxeqvlawvc (amlgwbqfyq, 56.0 - 90.3) View more |






