Last update 16 May 2024

Pembrolizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Lambrolizumab, Pembrolizumab (Genetical Recombination), Pembrolizumab (USAN)
+ [10]
Target
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (04 Sep 2014),
RegulationPRIME (EU), Orphan Drug (JP), Priority Review (AU), Breakthrough Therapy (US), Accelerated Approval (US)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Classical Hodgkin's Lymphoma
EU
17 Jul 2015
Classical Hodgkin's Lymphoma
LI
17 Jul 2015
Classical Hodgkin's Lymphoma
IS
17 Jul 2015
Metastatic Biliary Tract Carcinoma
EU
17 Jul 2015
Metastatic Biliary Tract Carcinoma
IS
17 Jul 2015
Metastatic Biliary Tract Carcinoma
NO
17 Jul 2015
Metastatic Biliary Tract Carcinoma
LI
17 Jul 2015
Metastatic Gastric Carcinoma
EU
17 Jul 2015
Metastatic Gastric Carcinoma
NO
17 Jul 2015
Metastatic Gastric Carcinoma
LI
17 Jul 2015
Metastatic Gastric Carcinoma
IS
17 Jul 2015
Recurrent Squamous Cell Carcinoma of the Head and Neck
IS
17 Jul 2015
Recurrent Squamous Cell Carcinoma of the Head and Neck
LI
17 Jul 2015
Recurrent Squamous Cell Carcinoma of the Head and Neck
NO
17 Jul 2015
Recurrent Squamous Cell Carcinoma of the Head and Neck
EU
17 Jul 2015
Uterine Cervical Cancer
IS
17 Jul 2015
Uterine Cervical Cancer
LI
17 Jul 2015
Uterine Cervical Cancer
NO
17 Jul 2015
Uterine Cervical Cancer
EU
17 Jul 2015
Melanoma
US
04 Sep 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced Endometrial CarcinomaNDA/BLA
US
21 Feb 2024
Recurrent Endometrial CancerNDA/BLA
US
21 Feb 2024
Locally Advanced CholangiocarcinomaNDA/BLA
US
08 Jun 2023
Metastatic Biliary Tract CarcinomaNDA/BLA
US
08 Jun 2023
Unresectable Biliary Tract CarcinomaNDA/BLA
US
08 Jun 2023
Small intestine carcinomaNDA/BLA
EU
25 Mar 2022
Stomach CancerNDA/BLA
EU
25 Mar 2022
PD-L1 positive Non-Small Cell Lung CancerPhase 3-25 Aug 2014
metastatic non-small cell lung cancerDiscovery-25 Aug 2014
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
26
(lgjilamdon) = cknhswjamf swsbbykope (fdzlqqczyx )
Positive
24 Apr 2024
Phase 2
53
Versamune® HPV + KEYTRUDA® (pembrolizumab)
(CPS ≥1)
(bkxouchmih) = ylgranmwog lltmmhrbyr (jfesqxpump )
Met
Positive
09 May 2024
Versamune® HPV + KEYTRUDA® (pembrolizumab)
(CPS≥20)
(bkxouchmih) = htqqffkewx lltmmhrbyr (jfesqxpump )
Met
Phase 2
50
(cqsyitnfwy) = tdzjnemiap nqksbitktf (wcdoaktuqj, 61.9 ~ 86.9)
Positive
05 Apr 2024
Phase 2
6
(qmvafonizc) = nottyvysgr yzlrhpyvxb (frfmnwgnyt )
Positive
02 May 2024
Phase 1
41
(hvpgxupxec) = siinmfyeyx hrztssrara (cmunqpfrsd )
Positive
05 Apr 2024
Phase 2
55
(ihrtdhlkfp) = bkbwlanrjd ipzjpaerjx (natkxnrkch )
Positive
06 May 2024
Pembrolizumab + Placebo
(ihrtdhlkfp) = fjbjyepoiu ipzjpaerjx (natkxnrkch )
Phase 1
15
(tcpsslzhqf) = not observed uilqpwrbfu (ogkemdoejc )
Positive
05 Apr 2024
Phase 3
591
(wgvxpgyhjy) = cjllqkwnjz aspzicaxyv (bhejmqcnem, 15.9 ~ 22.2)
Negative
05 Apr 2024
(wgvxpgyhjy) = gbcuzuswmm aspzicaxyv (bhejmqcnem, 16.0 ~ 21.6)
Phase 3
-
pembrolizumab+Chemotherapy
(wlmdijbzyz) = The safety profile of KEYTRUDA was consistent with that observed in previously reported studies; no new safety signals were identified wpgeuwgwpj (vacogyatuc )
Negative
09 May 2024
placebo+Chemotherapy
Phase 1
41
(bmhvoitnff) = The most common treatment-related AEs were fatigue (51.2%), pruritus (51.2%), and alopecia (46.3%). zzwtfsmsaw (ojqberoabk )
Positive
05 Apr 2024
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