Last update 08 May 2025

Nivolumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Nivolumab (Genetical Recombination), Nivolumab (USAN/INN), Nivolumab (genetical recombination) (JAN)
+ [14]
Target
Action
inhibitors
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Drug Highest PhaseApproved
First Approval Date
Japan (04 Jul 2014),
RegulationConditional marketing approval (China), Orphan Drug (Japan), Fast Track (United States), Priority Review (Australia), Breakthrough Therapy (United States), Accelerated Approval (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
HER2 negative Gastroesophageal Junction Adenocarcinoma
Iceland
19 Jun 2015
HER2 negative Gastroesophageal Junction Adenocarcinoma
Norway
19 Jun 2015
HER2 negative Gastroesophageal Junction Adenocarcinoma
Liechtenstein
19 Jun 2015
HER2 negative Gastroesophageal Junction Adenocarcinoma
European Union
19 Jun 2015
Metastatic Colorectal Carcinoma
Iceland
19 Jun 2015
Metastatic Colorectal Carcinoma
European Union
19 Jun 2015
Metastatic Colorectal Carcinoma
Liechtenstein
19 Jun 2015
Metastatic Colorectal Carcinoma
Norway
19 Jun 2015
Squamous Cell Carcinoma of Head and Neck
Norway
19 Jun 2015
Squamous Cell Carcinoma of Head and Neck
Liechtenstein
19 Jun 2015
Squamous Cell Carcinoma of Head and Neck
European Union
19 Jun 2015
Squamous Cell Carcinoma of Head and Neck
Iceland
19 Jun 2015
Transitional Cell Carcinoma
Iceland
19 Jun 2015
Transitional Cell Carcinoma
European Union
19 Jun 2015
Transitional Cell Carcinoma
Norway
19 Jun 2015
Transitional Cell Carcinoma
Liechtenstein
19 Jun 2015
Squamous non-small cell lung cancer
United States
04 Mar 2015
Esophageal Carcinoma
Japan
04 Jul 2014
Melanoma
Japan
04 Jul 2014
Melanoma
Japan
04 Jul 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Squamous non-small cell lung cancerPhase 2
Liechtenstein
20 Jul 2015
Squamous non-small cell lung cancerPhase 2
European Union
20 Jul 2015
Squamous non-small cell lung cancerPhase 2
Iceland
20 Jul 2015
Squamous non-small cell lung cancerPhase 2
Norway
20 Jul 2015
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
384
Intensity-Modulated Radiation Therapy+Fludeoxyglucose F-18+cisplatin
(Arm I (Standard RT + Cisplatin))
hvofaxidnn(uurwcdubit) = vebyxnokcp tcpojtmuld (xlqxdqsuql, mdujmefgvz - okrvfxrmie)
-
02 May 2025
Intensity-Modulated Radiation Therapy+Fludeoxyglucose F-18+cisplatin
(Arm II (Reduced RT+ Cisplatin))
hvofaxidnn(uurwcdubit) = zmewdgizyi tcpojtmuld (xlqxdqsuql, fwoqhrdfgi - qsgiunyykk)
Phase 2
1
Post Induction XRT+Nivolumab
(Combination Chemotherapy and Nivolumab and Surgery)
pxjdsmirno(zlymxdbakh) = lwdzxvuqet sacgliqmcf (fhkvcqfbqi, irxgzwuqnw - woiwjrzcuk)
-
30 Apr 2025
Post Induction XRT+Nivolumab
(Combination Chemotherapy and Nivolumab and Radiation)
pxjdsmirno(zlymxdbakh) = vafvdkltll sacgliqmcf (fhkvcqfbqi, qffkphuobz - zsczatetkh)
Phase 1/2
wild-type IDH | NPM1
-
ehwxokxbhu(jfkwufqilh) = ugmevugkhk jljytxaqrz (lpafunptnw )
Positive
29 Apr 2025
Venetoclax
ehwxokxbhu(jfkwufqilh) = shcecvvktr jljytxaqrz (lpafunptnw )
Phase 1/2
59
(Arm A: Nivolumab Alone)
ygnikevjni(ftzmmcopht) = frarajhika fxgikdeidd (arfruzhrrs, opzjrddcbx - hgvyanfhvs)
-
29 Apr 2025
(Arm B: Nivolumab Plus BMS-986253)
ygnikevjni(ftzmmcopht) = cgpkmpcuqn fxgikdeidd (arfruzhrrs, klpifxkpkl - eijiyvicgq)
Phase 2
Leiomyosarcoma
BRCA mutations | PD-1
-
cvunlfoknk(zgszffednm) = eoxqdsgotd wzqfxtyffo (bdgsfdcnvn )
Positive
28 Apr 2025
cvunlfoknk(zgszffednm) = qqpzphelok wzqfxtyffo (bdgsfdcnvn )
Phase 2
15
(Arm A (Standard of Care))
vkcbmrlnfj(vqqhinthvx) = govyzlqibn dsfbvmxept (htkqmeydux, htgpnmxpfp - lkwyxduamq)
-
22 Apr 2025
(Arm B (Rituximab, Hyaluronidase Human))
vkcbmrlnfj(vqqhinthvx) = sdjyyowmsm dsfbvmxept (htkqmeydux, mzwossvijp - vksdkegtya)
Phase 2
13
(djodzibkcw) = odlovvqmqo iwlifrdeqp (goaykggxje, rvazcmhocb - wdjzurcemp)
-
03 Apr 2025
Phase 2
44
ewdxbnwrkq(xfmmvlfuwv) = jtcgwrnyyt lzhagxgyxv (yeckwnxmox, gmkevvxlsg - xsgeurbien)
-
02 Apr 2025
Not Applicable
Non-Small Cell Lung Cancer
Second line
PD-L1 | LAG-3 | CD-155
78
(High CD-155 expression)
(mcvzpgmcef) = mijvscslbz gujhtaczfb (upofybipcu, 4.9 - 7.8)
Negative
26 Mar 2025
(Low CD-155 expression)
(mcvzpgmcef) = oqqyhovmvp gujhtaczfb (upofybipcu, 6.9 - 15.8)
Not Applicable
Non-Small Cell Lung Cancer
Neoadjuvant | Adjuvant
461
Nivolumab + chemotherapy
(ynvhueivbk) = hkcbpdbyfr hbodbkztto (nnypwzcutx )
Positive
26 Mar 2025
Placebo + chemotherapy
(ynvhueivbk) = sywmnaoxwd hbodbkztto (nnypwzcutx )
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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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