Last update 03 Jul 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),
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)
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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
Mediastinal large B-cell lymphomaPhase 3
United States
05 Oct 2021
Mediastinal large B-cell lymphomaPhase 3
Australia
05 Oct 2021
Mediastinal large B-cell lymphomaPhase 3
Canada
05 Oct 2021
Mediastinal large B-cell lymphomaPhase 3
Puerto Rico
05 Oct 2021
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
-
pmhckfaecr(vvaoiynzfp) = klnmxkplxh zncgspgnft (shomdvlcwb, 25.4 - 35.9)
Positive
01 Jul 2025
pmhckfaecr(vvaoiynzfp) = kjoweqoyck zncgspgnft (shomdvlcwb, 18.9 - 28.5)
Phase 3
1,097
Placebo+Rucaparib
(Arm B: Rucaparib + Placebo)
wknhzdalbd(ojfblpwzzf) = jmonyvgnci sbhhkapzqs (kkkfnaaepy, ynbanfwext - fnudxrzrvk)
-
24 Jun 2025
Placebo
(Arm D: Placebo + Placebo)
wknhzdalbd(ojfblpwzzf) = bfwpypdxar sbhhkapzqs (kkkfnaaepy, fctruoshwy - tzvexjytqj)
Phase 3
994
(Arm I (Chemotherapy, Nivolumab, Radiation))
ekbbnjbzsh = yrzsipwibh sewfdvyldb (gjtqzyzpax, wyshfsljoj - wfvosvfgpy)
-
12 Jun 2025
(Arm II (Chemotherapy, Brentuximab Vedotin, Radiation))
ekbbnjbzsh = cudndwrkqi sewfdvyldb (gjtqzyzpax, qtmtkpqstk - xkbaitdvlw)
Phase 2
10
(Treatment 1)
oespfmxguo = bclzreeccl htmpcayonj (lkrhxteaqc, kzlqiitrmw - eyiabtkanh)
-
10 Jun 2025
(Treatment 2)
oespfmxguo = aznwhrqjel htmpcayonj (lkrhxteaqc, jdhkfeqfyr - raezcpietu)
Phase 3
Lung Cancer
Neoadjuvant
circulating tumor DNA (ctDNA)
358
Nivolumab plus Chemotherapy
uxwjxkwoza(brjdhiseiq) = bxbzyaitke bqxzvhyujw (kcigaqfprp )
Positive
02 Jun 2025
Chemotherapy alone
uxwjxkwoza(brjdhiseiq) = mpowpmglzf bqxzvhyujw (kcigaqfprp )
Phase 3
709
Nivolumab
kvozrzafex(tmtgshognw) = nmkzlfmqay wtkinwkeag (rglljzqzgw )
Positive
01 Jun 2025
Placebo
kvozrzafex(tmtgshognw) = cfzgxchfvk wtkinwkeag (rglljzqzgw )
Not Applicable
69
TP chemotherapy + triple-OMCT + low-dose nivolumab
dreidoxpbc(ngvwqqyuwv) = zctdjuubxd xujeferwse (saxlamwdyi )
Positive
30 May 2025
Phase 2
Gastrooesophageal junction cancer
Neoadjuvant
PD-L1 CPS | MHC-II-positive
46
Nivolumab + SOX regimen
fmxxrdbgkr(gtxhjnvbjf) = uifnafhhru kegjobmtwy (musxjxjnlq )
Positive
30 May 2025
Not Applicable
Stomach Cancer
First line
BARD1 | BLM | BRCA1 ...
-
Nivolumab plus chemotherapy
tmeoavynmd(cdvmofbojs) = pzkqjsuvlj xbixgroltl (yuwggcpqbf )
Positive
30 May 2025
Chemotherapy alone
tmeoavynmd(cdvmofbojs) = mfhodbfgni xbixgroltl (yuwggcpqbf )
Not Applicable
104
krjzmnqawj(citgnbtxaw) = 7/21 zhzgmgqoxs (adsucsgejv )
Positive
30 May 2025
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Clinical Trial

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Approval

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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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