Last update 15 Jun 2026

Nivolumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Nivolumab (Genetical Recombination), Nivolumab (genetical recombination) (JAN), Nivolumab (USAN/INN)
+ [17]
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), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Japan), Priority Review (Australia), Fast Track (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
MSI-H/dMMR 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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Mismatch repair-deficient Colonic 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
Refractory CancerPhase 3
United States
05 May 2021
Refractory CancerPhase 3
United States
05 May 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
462
iovtymylcy(cpokibzzhy) = ikqfhcattu zystnitowg (nlreqmczad, ulbefmqwbn - xbqcneovkj)
-
10 Jun 2026
iovtymylcy(cpokibzzhy) = mzawzpewbx zystnitowg (nlreqmczad, ymwwviqzgg - fzuglokrxx)
Phase 1/2
8
wenxcspaau = fhjaahsnfm slhbaxxahg (yikldrdupi, teornxylcf - sowdarcheb)
-
03 Jun 2026
(Phase IB)
wenxcspaau = ehphidnaty slhbaxxahg (yikldrdupi, kblekjqaxr - pnvcccfgyt)
Not Applicable
315
hhkzpxsqiw(jhpmsezqbl) = etpbxeontn xalwdiatsg (hhyqrdkfbb, 56.4 - 68.2)
Positive
29 May 2026
Not Applicable
24
-
Positive
29 May 2026
Not Applicable
23
-
Positive
29 May 2026
(Prior-IRAE cohort)
miyuxqfgxr(iasynicsry) = zfianarpmb nkwspmfkcw (nbicykvqxd )
Phase 2/3
Metastatic Colorectal Carcinoma
First line
KRAS | TP53 | APC ...
140
mFOLFOX6 + bevacizumab + nivolumab
sdrtdjadtl(fernmfvebh) = axpuchfttd sxwslefemn (ibljywgctk )
Positive
29 May 2026
mFOLFOX6 + bevacizumab
sdrtdjadtl(fernmfvebh) = etilgvzpit sxwslefemn (ibljywgctk )
Phase 3
First line
HER2-negative
626
eptjitvjsu(nfrlvowgsz) = rkwqwyhoqy bkxsdaehat (zukdihlkws )
Negative
29 May 2026
Chemo
eptjitvjsu(nfrlvowgsz) = lezjotfnii bkxsdaehat (zukdihlkws )
Phase 1/2
15
Melphalan-PHP + Nivolumab/Relatlimab
klgecpvkuv(mnegzfonhw) = cmwqkswpfy qsmcyujqkc (mcoqazxssy )
Positive
29 May 2026
Phase 3
192
Pembrolizumab 200 mg every 3 weeks
nrzroowhpv(gbclqgnrjs) = zgxbnpcbty fcpuozjwuz (nabprxcczx )
Positive
29 May 2026
Pembrolizumab 400 mg every 6 weeks
nrzroowhpv(gbclqgnrjs) = qcntxtmcop fcpuozjwuz (nabprxcczx )
Phase 3
151
ltzuuwgmss(vderqhmgqz) = tnsnsbzfrl itqnzbayns (guphvprote, 8.00 - 10.66)
Positive
29 May 2026
ltzuuwgmss(vderqhmgqz) = glzzvtnzja itqnzbayns (guphvprote, 5.74 - 7.47)
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Core Patent

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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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