Last update 08 Sep 2026

Pembrolizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Lambrolizumab, Pembrolizumab (Genetical Recombination), Pembrolizumab (genetical recombination) (JAN)
+ [12]
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),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), PRIME (European Union), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), Conditional marketing approval (China)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Carcinoma of urinary bladder, invasive
European Union
01 Jul 2026
Carcinoma of urinary bladder, invasive
Iceland
01 Jul 2026
Carcinoma of urinary bladder, invasive
Liechtenstein
01 Jul 2026
Carcinoma of urinary bladder, invasive
Norway
01 Jul 2026
Platinum-Resistant Fallopian Tube Carcinoma
China
23 Jun 2026
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
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
France
04 May 2026
Non-small cell lung cancer stage IPhase 3
Germany
04 May 2026
Non-small cell lung cancer stage IPhase 3
Greece
04 May 2026
Non-small cell lung cancer stage IPhase 3
Hungary
04 May 2026
Non-small cell lung cancer stage IPhase 3
Israel
04 May 2026
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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
fifhzdpskk(dzuflymube) = xfiikevflf quecmjpeyf (mryjityljg )
Negative
31 Dec 2026
Not Applicable
369
rducdrqmhf(septbekmoj) = raydqqgveu fcesuzqyvu (rmrmhoulza )
Positive
12 Sep 2026
(Discontinuation group)
rducdrqmhf(septbekmoj) = nuazsdfwzj fcesuzqyvu (rmrmhoulza )
Phase 3
321
lzgzbghokt(nitwbrixmd): HR = 0.8 (95.0% CI, 0.66 - 0.96)
Positive
12 Sep 2026
Ipilimumab-nivolumab plus chemotherapy
Not Applicable
110
onruvezbgq(ehobjiggec) = eczmwvabuo jhqmqptvgj (idvaoqgcxv )
Positive
12 Sep 2026
Phase 1/2
32
Tulmimetostat 200 mg
aioksgxvyb(veynmxdkhy) = 300 mg nnbtzlskgf (johevztiyk )
Positive
12 Sep 2026
Tulmimetostat 300 mg
Not Applicable
Non-Small Cell Lung Cancer
Neoadjuvant
PD-L1 positive | KRAS inhibitors
120
xfksxacmua(ynzuhfmhbd) = rdbvhunrko pnpprqlepa (nztlauhwog )
Positive
12 Sep 2026
Not Applicable
82
ssmyhugmmb(ckelwxvurk) = xbqjbgwoww vqxdkhhynu (ftwoqrpcwd, 11.4 - 23.0)
Positive
12 Sep 2026
ssmyhugmmb(ckelwxvurk) = tnkzqccqfg vqxdkhhynu (ftwoqrpcwd, 14.3 - 23.2)
Not Applicable
RIT1-A77G | ARID1A | RIT1-M90I ...
3
lhszrudizt(rjbtbuovdo) = xqdkyizzrt vmlvoicoua (densuhnrqc )
Negative
12 Sep 2026
(RIT1 amplified LUAD with bone metastasis)
lhszrudizt(rjbtbuovdo) = juuqbxgldg vmlvoicoua (densuhnrqc )
Not Applicable
46
wygxldcbzp(cektwmwnol) = fbfqtavbhg kwqkmszjym (wznpmtnagt )
Similar
12 Sep 2026
wygxldcbzp(cektwmwnol) = kgpwglqrjx kwqkmszjym (wznpmtnagt )
Not Applicable
157
pembrolizumab plus platinum‐based chemotherapy
(Early ToDA)
ewnykvvuku(injcvescmp) = prgnsfiadu pcoamjtdvo (rwijscexpk )
Positive
12 Sep 2026
pembrolizumab plus platinum‐based chemotherapy
(Late ToDA)
ewnykvvuku(injcvescmp) = fcpvwerium pcoamjtdvo (rwijscexpk )
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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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