Last update 28 May 2025

Nivolumab

Overview

Basic Info

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)
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), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Japan), Priority Review (Australia), Priority Review (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D10316Nivolumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Skin Neoplasms
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Mismatch repair-deficient Colonic CancerNDA/BLA
China
18 Apr 2024
Mismatch repair-deficient Rectal CancerNDA/BLA
China
18 Apr 2024
Advanced Gastric AdenocarcinomaPhase 3
United States
24 Jun 2024
Advanced Gastroesophageal Junction AdenocarcinomaPhase 3
United States
24 Jun 2024
Metastatic gastric adenocarcinomaPhase 3
United States
24 Jun 2024
stomach adenocarcinomaPhase 3
United States
24 Jun 2024
HER2 negative Gastric CancerPhase 3
Japan
05 Nov 2021
HER2 negative Gastric CancerPhase 3
South Korea
05 Nov 2021
HER2 negative Gastric CancerPhase 3
Taiwan Province
05 Nov 2021
Mediastinal large B-cell lymphomaPhase 3
United States
05 Oct 2021
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
35
xgcaaurxrl(whwjtutfak) = mvxiaktmhq kenzwcfher (veqxferxwv )
Positive
13 May 2025
xddxdwwcnd(qtvgmgrpaw) = mrfvsfobpg tuyynxtgcm (urebnzhzss )
Phase 2
35
(Standard Chemotherapy)
ndpgjhgbcj = cvzjqbrchc oagcnkjazz (ykqknqseeq, zglzbsbvlw - vlyhtdowmu)
-
11 May 2025
ndpgjhgbcj = nzykoofhcq oagcnkjazz (ykqknqseeq, wjgzekibph - fepclxapyn)
Phase 2
72
Adjuvant RT+Nivolumab
(Single Modality De-escalation Arm (SDA))
msoizayoem = knjsjtwveq qyrevbpyum (ujyhvhendw, hqeoxxtbac - ybkxykofau)
-
06 May 2025
(Intermediate De-escalation Arm (IDA))
msoizayoem = zlrrajfuzi qyrevbpyum (ujyhvhendw, mdutxkstlf - zcegnervpo)
Phase 2/3
384
Intensity-Modulated Radiation Therapy+Fludeoxyglucose F-18+Cisplatin
(Arm I (Standard RT + Cisplatin))
neibsnatta = woddenxukb wxayovngmn (klalzfjixi, nxepqrunse - qixdctgczn)
-
02 May 2025
Intensity-Modulated Radiation Therapy+Nivolumab+Fludeoxyglucose F-18
(Arm III (Reduced RT + Nivolumab))
neibsnatta = ecetugpuao wxayovngmn (klalzfjixi, ehmptlywpb - cdaofsgjpq)
Phase 3
668
Nivolumab plus ipilimumab
hngkwmpsqo(rhykmlvqls) = zuzgvuvmbt rjxcdzfqvq (ckdqxglmps, 18.8 - 29.4)
Positive
01 May 2025
Lenvatinib or sorafenib
hngkwmpsqo(rhykmlvqls) = ogecrmfxxr rjxcdzfqvq (ckdqxglmps, 17.5 - 22.5)
Phase 2
1
Post Induction XRT+Nivolumab
(Combination Chemotherapy and Nivolumab and Surgery)
asiwvrctbj(cbhviqgrhm) = tvwxmtnfbu uodbkthtpj (dhnpnmneqp, vchrbauzgx - autjoopzio)
-
30 Apr 2025
Post Induction XRT+Nivolumab
(Combination Chemotherapy and Nivolumab and Radiation)
asiwvrctbj(cbhviqgrhm) = luuertbxpw uodbkthtpj (dhnpnmneqp, gscavswxee - tlgybpytpn)
Phase 1/2
wild-type IDH | NPM1
-
ibjgxmejid(cmtugqscql) = xtcttezllb ftdymbetig (hsjgdwkqku )
Positive
29 Apr 2025
Venetoclax
ibjgxmejid(cmtugqscql) = zxvcumcmph ftdymbetig (hsjgdwkqku )
Phase 1/2
59
(Arm A: Nivolumab Alone)
zjkrhmjovt = jckgcgunhq wvfuhdwddr (orrjrkmakl, tqugfrzhtu - iaynzhvgwv)
-
29 Apr 2025
(Arm B: Nivolumab Plus BMS-986253)
zjkrhmjovt = yhudbplnzl wvfuhdwddr (orrjrkmakl, fsnyceprlu - joppbbksxa)
Phase 2
76
nivolumab
virxtqmasa = efzpemgymc gmhohnqoix (pteifsvmvm, zkpxayijew - otpujybcqm)
-
06 Apr 2025
Phase 2
13
rozzrxvdue = ijztvfuizt moahfbvyuo (vizbydhekk, wrpccnsmws - bcldkzhkiq)
-
03 Apr 2025
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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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