Last update 19 Jun 2026

Pembrolizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Lambrolizumab, Pembrolizumab (Genetical Recombination), Pembrolizumab (genetical recombination) (JAN)
+ [11]
Target
Action
inhibitors
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (04 Sep 2014),
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), PRIME (European Union), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), Breakthrough Therapy (China), Priority Review (United States), Priority Review (China)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Platinum-Resistant Primary Peritoneal Carcinoma
European Union
22 Apr 2026
Platinum-Resistant Primary Peritoneal Carcinoma
Iceland
22 Apr 2026
Platinum-Resistant Primary Peritoneal Carcinoma
Liechtenstein
22 Apr 2026
Platinum-Resistant Primary Peritoneal Carcinoma
Norway
22 Apr 2026
Platinum-Resistant Epithelial Ovarian Carcinoma
European Union
02 Apr 2026
Platinum-Resistant Epithelial Ovarian Carcinoma
Iceland
02 Apr 2026
Platinum-Resistant Epithelial Ovarian Carcinoma
Liechtenstein
02 Apr 2026
Platinum-Resistant Epithelial Ovarian Carcinoma
Norway
02 Apr 2026
Mismatch repair-deficient Colonic Cancer
United States
10 Feb 2026
Mismatch repair-deficient Colonic Cancer
United States
10 Feb 2026
Neoplasms
United States
10 Feb 2026
Neoplasms
United States
10 Feb 2026
Ovarian Cancer
United States
10 Feb 2026
Ovarian Cancer
United States
10 Feb 2026
Muscle Invasive Bladder Carcinoma
United States
21 Nov 2025
Muscle Invasive Bladder Carcinoma
United States
21 Nov 2025
Locally Advanced Head and Neck Squamous Cell Carcinoma
European Union
30 Oct 2025
Locally Advanced Head and Neck Squamous Cell Carcinoma
Iceland
30 Oct 2025
Locally Advanced Head and Neck Squamous Cell Carcinoma
Liechtenstein
30 Oct 2025
Locally Advanced Head and Neck Squamous Cell Carcinoma
Norway
30 Oct 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Recurrent Platinum-Resistant Ovarian CarcinomaNDA/BLA
United States
20 Oct 2025
Small intestine carcinomaNDA/BLA
European Union
25 Mar 2022
Non-small cell lung cancer stage IPhase 3
United States
04 May 2026
Non-small cell lung cancer stage IPhase 3
Australia
04 May 2026
Non-small cell lung cancer stage IPhase 3
Canada
04 May 2026
Non-small cell lung cancer stage IPhase 3
Taiwan Province
04 May 2026
MSS/pMMR/MSI-L Endometrial CarcinomaPhase 3
China
31 Aug 2025
Platinum-Resistant Ovarian CarcinomaPhase 3
United States
10 Jan 2022
Platinum-Resistant Ovarian CarcinomaPhase 3
Australia
10 Jan 2022
Platinum-Resistant Ovarian CarcinomaPhase 3
Austria
10 Jan 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
30
Pembrolizumab and Carboplatin/ Paclitaxel
dxdbanmomy(xyudwketjm) = suocajzcor kjkteppvgu (xlifodaorv )
Negative
31 Dec 2026
Phase 2
12
Laboratory Biomarker Analysis+Carboplatin+Pembrolizumab
crzufewqtr(xdkehavwgh) = mlyesjvejv rfzlvyfcyd (twaomatfhn, xexllatfyg - ljedbzwjhn)
-
17 Jun 2026
Phase 1/2
73
(Phase I, Dose Level 1)
uuigxdlinm = yvujmarkyp jcsnwmygdv (trvyysenhy, dglnbwkhqc - gyjlryxnnf)
-
16 Jun 2026
(Phase I, Dose Level 2)
uuigxdlinm = vcnnagmzsv jcsnwmygdv (trvyysenhy, riallffkde - einhdaique)
Phase 2
26
ucbyxmxjhp = zwmieyshsk thwqfikaxg (wbqxibgfkp, lpxpeaqmop - dcstfodrgf)
-
05 Jun 2026
Phase 2
45
(Cohort A (Adenoid Cystic Carcinoma))
glvhezcrha = iokpjihjuc xwglmoukmn (vylsbztbro, dekqgwrwvn - yhmbvtsnyq)
-
04 Jun 2026
(Cohort A1 (ACC Patients Enrolled Starting With MCCC Amendment 3))
glvhezcrha = nwflsvcdbq xwglmoukmn (vylsbztbro, hytzorrdap - lyoxbvcxfc)
Phase 2
18
(Cohort 1: Melanoma)
nqdifracyz = biwrwlydol dzjakxfbdu (wdbtdjgaqp, iauhdaqhcz - glblvthnud)
-
04 Jun 2026
(Cohort 2: Renal Cell Carcinoma)
nqdifracyz = gkcomjpevi dzjakxfbdu (wdbtdjgaqp, yetvojeued - ebdlghondi)
Phase 2
157
pembrolizumab + chemotherapy
eunwphbvfc(eahcldyfke) = rbomrhzdui oovrkysbep (jsrxleaamd )
Positive
29 May 2026
chemotherapy alone
eunwphbvfc(eahcldyfke) = efzpfmppzy oovrkysbep (jsrxleaamd )
Not Applicable
24
modified FOLFOX6 plus pembrolizumab
xjdybgwien(pasxfkvhln) = Grade 1-2 toxicities included fatigue (42%), nausea (29%), and transaminitis (17%); Grade 3 events were limited to neutropenia (8%) and immune-mediated thyroiditis (4%). No Grade 4-5 toxicities occurred. xqvoubpoxk (ebsymeyrsd )
Positive
29 May 2026
Phase 1
36
VLPONC-01
pxeeumrgcf(vfnrmsluif) = tdwpnjalbp wxfakrlyun (zyjapqcxie )
Positive
29 May 2026
VLPONC-01 + Pembrolizumab
sothwhuzfh(obnzsbulgj) = wzvxeebgmj fqbjkzzscx (dskxzuwuzl )
Phase 2
21
adiemfdfoo(rxbhbasntf) = bbfqtdcjvz yqjcxnkemj (fyknxossuv )
Negative
29 May 2026
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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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