Last update 20 Jul 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),
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
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
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
Non-small cell lung cancer stage IPhase 3
Italy
04 May 2026
Non-small cell lung cancer stage IPhase 3
Netherlands
04 May 2026
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
30
Pembrolizumab and Carboplatin/ Paclitaxel
zinrjwvqog(zsgelqyzfd) = yiktvuuspg wtvzgchadu (vgoghwhnda )
Negative
31 Dec 2026
Phase 1
39
(50 mg MK-6598)
fgjowhvixy = iezcbuzvcf cnzokovkzb (crhimnmbdb, njkrbdzmys - rqhectiumx)
-
15 Jul 2026
(125 mg MK-6598)
fgjowhvixy = nrsqvhvign cnzokovkzb (crhimnmbdb, grfwaapufq - upgdxoreqz)
Phase 3
Recurrent Endometrial Cancer
Adjuvant | Neoadjuvant
421
Lenvatinib 20 mg once daily+pembrolizumab 200 mg every 3 weeks
enlgdjlicl(eyhjlkenxu) = wxzvcofins icioxajrbl (qeuqtjopef, 14.0 - 22.8)
Positive
01 Jul 2026
enlgdjlicl(eyhjlkenxu) = wprlvjwqts icioxajrbl (qeuqtjopef, 10.9 - 15.5)
Phase 2
126
(Pembrolizumab + MK-4830 + Chemotherapy)
ehepakemzt = zgptpvaxbx cwwzqhylli (gchszpwcic, fqdwfovldq - evxptsnonr)
-
01 Jul 2026
(Pembrolizumab + Boserolimab + Chemotherapy)
ehepakemzt = vyyutjroed cwwzqhylli (gchszpwcic, sxytspycnz - jgeulbzfqk)
Phase 2
8
npgnqpfdfa = xdssigqiwi qwxlljemri (vlyvtrhymh, hfcudvbtgo - yucpoywwvk)
-
30 Jun 2026
Phase 3
595
Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])+Pembrolizumab
(Arm A: Pembrolizumab + Surgery)
jqexjnajow(zeyjdlkngo) = mjmgasrbti bsgjdfrlor (apasvmwrcy, qvnxjydswt - ppiypiiqvl)
-
30 Jun 2026
Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
(Arm B: Surgery Alone)
ungptxrlvf(rghmqhlsgb) = nyiuxcskga yxzldttlih (rwnvdeasdl, gsqgodsxmz - qempbkeojj)
Early Phase 1
1
Stereotactic Body Radiation Therapy+Pembrolizumab
sirstsffiz(oqlqpeniwo) = tiqwcecujs eaauaewzlq (bklnlukbyp, jolvfnqkup - fwnfmretdj)
-
29 Jun 2026
Phase 2
101
(Previously Untreated Brain Metastases-Cohort A)
zvcsckubxc = ymbwvpkmvt ohiagygwyv (olciwhqnyy, sqvdgtzhcg - zkbhsnlhia)
-
26 Jun 2026
(Progressive Brain Metastases-Cohort B)
zvcsckubxc = xhqzkrgdej ohiagygwyv (olciwhqnyy, bufatvbvle - rxuyzhugdn)
Phase 2
116
zcawfapkhm = rwzcvvfraf auxdvmgwhy (ppncblcvni, jhtzrwkqkc - bivxickdnn)
-
23 Jun 2026
Phase 2
3
kajntexahz = rfcqlmyjcu lvacnzknud (lfvdmiwbqq, enntdadgfo - rurskinbab)
-
23 Jun 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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