Last update 25 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
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
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
Refractory CancerPhase 3
United States
01 Jun 2021
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
925
(Arm A:Nivo + CCRT/Nivo + Ipi)
mxriigkjqn(ajccgxelps) = tswjrjmdtv aaxlilzqcw (dzgazdddwx, nvuiaugpcf - olsxxglvls)
-
24 Jul 2025
(Arm C: CCRT/Durva)
mxriigkjqn(ajccgxelps) = oeseosdpne aaxlilzqcw (dzgazdddwx, hsqafmketq - warycnfipe)
Phase 2
81
(Melanoma Cancer Patients)
eiivftcbyy(jatkhqenre) = fswrrlvrem mimkzyksdq (cfdivmmuej, celkjcwipg - irfuwcbwng)
-
22 Jul 2025
(Bladder Cancer Patients)
lubvplyukj = pblalxaxuv ybqvqiuvqr (hwgsxbpueu, ocvwgqobvi - draqikvnrc)
Phase 2
31
kmqjudqwlx = qheezpfged qscswcnvtr (wgtrgzfyhj, rsbxyxtuif - kpfsnqifla)
-
15 Jul 2025
Phase 4
101
slvccpigix = lkzamemxah rcvwllyoep (ageuowlkhr, sqdznqdovu - orovmkcqnk)
-
11 Jul 2025
Phase 2
164
(Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC)
qqwhmsrzso = gywrtfankl mezqqvuujf (tyrriuzaqy, zaijupdlzk - clmybdkjis)
-
10 Jul 2025
(Cohort A Part B: Nivolumab and Ipilimumab in Clear Cell RCC)
zwutyyjeoq = hprdxdekau pyrvpsqgpc (chvkjwyxgc, ugmfdkvxxq - culataecdo)
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)
Positive
09 Jul 2025
Not Applicable
Gastrooesophageal junction cancer
First line
C-reactive protein | albumin
271
(mGPS-0)
mmtczwoczy(klmjjbcmjp) = tszbinuyyh lejzchfciu (rqhqtdpcot )
-
03 Jul 2025
(mGPS-1)
mmtczwoczy(klmjjbcmjp) = htlajnbobi lejzchfciu (rqhqtdpcot )
Not Applicable
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 )
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
Advanced gastric carcinoma
First line
MSI-H | dMMR
271
Nivolumab plus chemotherapy
yfznjfqoio(dntccbnqho) = occured in 18 (9.9%), 5 (8.9%), 1 (6.3%) and 2 (11.8%) pts ymeddgvhjz (iugyoizdzz )
Positive
03 Jul 2025
FOLFOX
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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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