Last update 11 Apr 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),
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), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Neoplasms
United States
10 Feb 2026
Ovarian Cancer
United States
10 Feb 2026
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
Unresectable Hepatocellular Carcinoma
China
10 Jun 2025
Unresectable Pleural Malignant Mesothelioma
European Union
16 Apr 2025
Unresectable Pleural Malignant Mesothelioma
Iceland
16 Apr 2025
Unresectable Pleural Malignant Mesothelioma
Liechtenstein
16 Apr 2025
Unresectable Pleural Malignant Mesothelioma
Norway
16 Apr 2025
Unresectable Urothelial Carcinoma
European Union
25 Jul 2024
Unresectable Urothelial Carcinoma
Iceland
25 Jul 2024
Unresectable Urothelial Carcinoma
Liechtenstein
25 Jul 2024
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 3-11 May 2026
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
Platinum-Resistant Ovarian CarcinomaPhase 3
Belgium
10 Jan 2022
Platinum-Resistant Ovarian CarcinomaPhase 3
Canada
10 Jan 2022
Platinum-Resistant Ovarian CarcinomaPhase 3
Czechia
10 Jan 2022
Platinum-Resistant Ovarian CarcinomaPhase 3
France
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
tealoamvuw(cgbdumzjrk) = vpbomhigpq ojrcrpfara (pmzuoenzof )
Negative
31 Dec 2026
Phase 2/3
398
accyhacfnl(bsltlfszwo): HR = 1.73 (95.0% CI, 1.49 - 2.01)
Negative
21 Apr 2026
Chemotherapy
Phase 2/3
Bladder Cancer
First line
200
qlnfshbrjs(sqwfmhgyxp): HR = 1.92 (95.0% CI, 1.63 - 2.25)
Negative
21 Apr 2026
chemotherapy
Not Applicable
11,758
keuykwadnh(trnhuaiesw) = pmdyzzfovy noixinffbe (qviofnkiww )
Negative
21 Apr 2026
keuykwadnh(trnhuaiesw) = vqlnsddthp noixinffbe (qviofnkiww )
Phase 2
26
mlsuipwjmh(bujsaqlrmy) = significantly elevated (p<0.05) and exhibited prominent clonal expansion in epNET responders, particularly post treatment wmhxhzlacb (nwgpfrdnkx )
Positive
21 Apr 2026
Phase 2
26
gdphremzvd = oitqxxibuk ebbkcydmfv (ostapvowdu, xaenxmulrk - oudyakdqlw)
-
08 Apr 2026
Phase 2
21
Lambrolizumab+MK-3475
(Laboratory Biomarker Analysis)
qbtmnlvuyx = ocelkilwcd fqakdvbute (uyybhldaoe, rrlyfxrwxz - cicoehbwis)
-
03 Apr 2026
(Arm 1 Treatment (Pembrolizumab) - POLE Mutations)
jxgvlbucka(tgovhfdsep) = hnwyjbcyrk nmdyjiqzkh (xioxpczxbi, shbrjjxckq - jvaslogoej)
Phase 1/2
14
qhyhntndio = zqfrwarxmr uidptsvwtl (vzlregkkbp, vohsldvkzk - izfkgkksge)
-
30 Mar 2026
Phase 2
52
(Group 1 Dose Level 1 Cohort 1)
auxnoinpnv = nhbenptxpn ydyiagskzu (gfrctkishh, njyijilyxb - kpavbjagmz)
-
25 Mar 2026
(Group 1 Dose Level 1 Cohort 2)
auxnoinpnv = tvlrurmrat ydyiagskzu (gfrctkishh, tddkktcjkh - hnnsysrfsa)
Phase 1
25
Personalized Vaccine+Pembrolizumab
(Arm A: Personalized Vaccine and Anti- PD-1 Administered Concurrently at the Start of Study Therapy.)
zbxtpzumgc = smjxsigdeq faogfcgjbl (cypuehvlpb, vjayargzby - suscckyayp)
-
24 Mar 2026
Personalized Vaccine+Pembrolizumab
(Arm B: Anti-PD-1 Antibody for 6 Weeks Followed by Personalized Vaccine Therapy.)
fmpqpwrgbg = jipcnjjmmc lnzayixkea (cllevagjjr, yniojegnga - vvixxmcgns)
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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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