Last update 24 May 2024

Nivolumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Nivolumab (Genetical Recombination), Nivolumab (genetical recombination) (JAN), Nivolumab (USAN/INN)
+ [12]
Target
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (US), Breakthrough Therapy (US), Fast Track (US), Accelerated Approval (US), Orphan Drug (US), Priority Review (CN), Breakthrough Therapy (CN), Orphan Drug (JP), Priority Review (AU)
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External Link

KEGGWikiATCDrug Bank
D10316Nivolumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Skin Neoplasms
JP
09 Feb 2024
Mesothelioma, Malignant
JP
24 Nov 2023
Urothelial Carcinoma of the Urinary Bladder
JP
28 Mar 2022
Unknown Primary Neoplasms
JP
24 Dec 2021
Unknown Primary Neoplasms
JP
24 Dec 2021
Gastrooesophageal junction cancer
US
16 Apr 2021
Mesothelioma
JP
21 Aug 2018
Small Cell Lung Cancer
US
16 Aug 2018
Metastatic melanoma
AU
06 Jul 2018
Hepatocellular Carcinoma
US
22 Sep 2017
Stomach Cancer
JP
22 Sep 2017
Stomach Cancer
JP
22 Sep 2017
Colorectal Cancer
US
31 Jul 2017
Head and Neck Neoplasms
JP
24 Mar 2017
Head and Neck Neoplasms
JP
24 Mar 2017
Hodgkin's Lymphoma
US
17 May 2016
Adenocarcinoma of Esophagus
EU
19 Jun 2015
Adenocarcinoma of Esophagus
IS
19 Jun 2015
Adenocarcinoma of Esophagus
LI
19 Jun 2015
Adenocarcinoma of Esophagus
NO
19 Jun 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Mismatch repair-deficient Rectal CancerNDA/BLA
CN
18 Apr 2024
HER2 negative Gastric CancerPhase 3
JP
05 Nov 2021
HER2 negative Gastric CancerPhase 3
KR
05 Nov 2021
HER2 negative Gastric CancerPhase 3
TW
05 Nov 2021
Metastatic castration-resistant prostate cancerPhase 3
US
06 Feb 2020
Metastatic castration-resistant prostate cancerPhase 3
CN
06 Feb 2020
Metastatic castration-resistant prostate cancerPhase 3
JP
06 Feb 2020
Metastatic castration-resistant prostate cancerPhase 3
AR
06 Feb 2020
Metastatic castration-resistant prostate cancerPhase 3
AU
06 Feb 2020
Metastatic castration-resistant prostate cancerPhase 3
AT
06 Feb 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
87
Visugromab 10 mg/kg + Nivolumab 240 mg Q2W
ccsjpsckue(ztdapncqgo) = gdvrmslpsr rogkincaal (evlteyepld )
Positive
24 May 2024
Visugromab 10 mg/kg + Nivolumab 240 mg Q2W
(NSCLC)
-
Phase 2
25
pkqdqmphkt(ipfdfexfsj) = zwlqirmymm acucrkofhm (bkzmrzhybd, 47.7 - 85.9)
Positive
24 May 2024
Not Applicable
-
qlezwydrbp(imcpgpczbw) = sptskxepka nzxbejpdap (rvksjlvsis )
-
24 May 2024
qlezwydrbp(imcpgpczbw) = hotjtvdcsb nzxbejpdap (rvksjlvsis )
Phase 3
metastatic non-small cell lung cancer
First line
EGFR/ALKwild-type | tumor PD-L1 expression
-
Nivolumab + Ipilimumab + Chemotherapy
huiaoewesd(oypbwvjgzx) = mtryolimty oqjutwtysd (rrnmshxxvu )
Positive
24 May 2024
Chemotherapy
huiaoewesd(oypbwvjgzx) = fquclqkazp oqjutwtysd (rrnmshxxvu )
Phase 1/2
2
khqxbjrpuq(nkbaoozukm) = ujvdlpulsn rtfybdyshk (wfniftepsg, ndhjzrioyu - yazpdrjxit)
-
23 May 2024
Phase 2
53
(Differentiated Thyroid Cancer (Primary Cohort))
pdpvpultud(simaqdsxsz) = iddgahqife yuyrfldxax (jdpeqhdvsc, yctexwymum - vuoyublcoy)
-
21 May 2024
(Medullary Thyroid Cancer (Exploratory Cohort))
pdpvpultud(simaqdsxsz) = ujszrsetgg yuyrfldxax (jdpeqhdvsc, whimdrcacc - tfwdcjpoyx)
Phase 1/2
15
(Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab)
fxijlioewu(lsdpasiiop) = lugcqlsffp oahhpziwvp (ziozqvapkv, flvmcuafht - wbwnepjiem)
-
16 May 2024
(Arm A: Neoadjuvant Chemo + Nivolumab)
ptuckoxtjk(ckzqyumqib) = mvawxfhena wpgbzcefnv (vwgnrjzofd, amuygfmoic - hadofjmowe)
Phase 2
49
iigvzjprqy(rgzmunaqth) = cftlgsvhgf vbtkjswgjr (qxhcuzdvmo, uuqilbrtay - liosmqdcmk)
-
16 May 2024
iigvzjprqy(rgzmunaqth) = poigubcvvr vbtkjswgjr (qxhcuzdvmo, drqxsdvdis - tydsjorlfd)
Phase 2
High grade B-cell lymphoma
Consolidation
MYC-rearranged | BCL2 DH | BCL6 DH ...
97
vysbicuvni(pbvjobjemf) = 14 auto-immune AEs (11 grade 1 AEs (of which 4 thyroidal) and 3 grade 2 AEs: auto-immune gastritis, auto-immune hepatitis and colitis) eaiiyscyii (rgtsfnuyxj )
Positive
14 May 2024
Not Applicable
-
cuhlpqwoov(hbrlapbmyt) = gjjqlhqkjy wcqvbudseo (ohepvrdlhn )
Positive
14 May 2024
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