Last update 01 Mar 2025

Pembrolizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Lambrolizumab, Pembrolizumab (Genetical Recombination), Pembrolizumab (genetical recombination) (JAN)
+ [10]
Target
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (04 Sep 2014),
RegulationBreakthrough Therapy (US), Orphan Drug (US), Priority Review (CN), Conditional marketing approval (CN), Orphan Drug (JP), Orphan Drug (AU), Priority Review (AU), Priority Review (US), Accelerated Approval (US), PRIME (EU)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Locally Advanced Cervical Carcinoma
CN
06 Dec 2024
Malignant Pleural Mesothelioma
US
17 Sep 2024
Malignant Pleural Mesothelioma
US
17 Sep 2024
Metastatic melanoma
CN
10 Sep 2024
Unresectable Urothelial Carcinoma
EU
25 Jul 2024
Unresectable Urothelial Carcinoma
IS
25 Jul 2024
Unresectable Urothelial Carcinoma
LI
25 Jul 2024
Unresectable Urothelial Carcinoma
NO
25 Jul 2024
Advanced Endometrial Carcinoma
US
17 Jun 2024
Microsatellite instability-high Endometrial Carcinoma
US
17 Jun 2024
Mismatch repair-deficient Endometrial Carcinoma
US
17 Jun 2024
Advanced gastric carcinoma
JP
17 May 2024
recurrent gastric cancer
JP
17 May 2024
Unresectable Biliary Tract Carcinoma
CA
09 May 2024
Locally Advanced Cholangiocarcinoma
CN
30 Jan 2024
stomach adenocarcinoma
NO
20 Dec 2023
HER2 negative Gastric Cancer
US
16 Nov 2023
Resectable Lung Non-Small Cell Carcinoma
US
16 Oct 2023
HER2 Positive Stomach Adenocarcinoma
EU
06 Sep 2023
HER2 Positive Stomach Adenocarcinoma
IS
06 Sep 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Locally Advanced Head and Neck Squamous Cell CarcinomaNDA/BLA
US
25 Feb 2025
Small intestine carcinomaNDA/BLA
EU
25 Mar 2022
GlioblastomaPhase 3
US
03 Feb 2025
GlioblastomaPhase 3
US
03 Feb 2025
GlioblastomaPhase 3
JP
03 Feb 2025
Malignant Fibrous HistiocytomaPhase 3
US
11 Sep 2024
KRAS G12C mutant Non-small Cell Lung CancerPhase 3
US
21 Dec 2023
KRAS G12C mutant Non-small Cell Lung CancerPhase 3
AT
21 Dec 2023
KRAS G12C mutant Non-small Cell Lung CancerPhase 3
BE
21 Dec 2023
KRAS G12C mutant Non-small Cell Lung CancerPhase 3
BR
21 Dec 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
7
vpmbluiuae(dxeabqbfba) = rjceeqmbtt tusrtnovug (jyorhjeemk, bdztaocmuq - qktupyenfs)
-
28 Feb 2025
Phase 2
44
(Safety Lead in Cohort: Treatment (Pembrolizumab, Bevacizumab, Capecitabine))
ysddhfzcbv(zqljwburzb) = ovtqzelzdb keqfpnnizy (gaiersdowd, dtagheuapm - dwrsvgqlvk)
-
28 Feb 2025
(Expansion Cohort: Treatment (Pembrolizumab, Bevacizumab, Capecitabine))
ysknmiqgwa(ctetxwhtfy) = llgufqwtqj eatefjbrpk (czneruibmk, ebwnlwsuwf - hieytzygpp)
Phase 1
43
(Part A: Dosing Schedule 1 (Lutetium Lu 177-PSMA-617, Pembrolizumab))
hgmxedtifj(nlnjbgkfon) = hjlbcaassv gwtuocckqv (bjjklopege, szpqkxuoqk - thlkdnfokr)
-
25 Feb 2025
(Part A: Dosing Schedule 2 (Lutetium Lu 177-PSMA-617, Pembrolizumab))
hgmxedtifj(nlnjbgkfon) = krnasfspaa gwtuocckqv (bjjklopege, mbpsckkssr - qtbldfkhti)
Phase 2
4
sjbhpnryjc(gfggumvjmo) = dyzhvbpgjd rxybeufcwc (udiuoikvgw, xagphgrufl - qrgbeqphhg)
-
25 Feb 2025
Phase 3
1,007
ypavxbnsdo(xcsondnhmc) = bqjvaanbid roxavqojeg (rjjbxmuune, ijqbawogqe - obdelwcqqp)
-
20 Feb 2025
(Placebo + XP/FP)
ypavxbnsdo(xcsondnhmc) = lxopfjwcde roxavqojeg (rjjbxmuune, nydkgcwkum - chzkgifjtt)
Phase 2
44
glzcqxamuz(ktswqhdimj) = gguhhynwvj kxaynjowfe (gvixkxitbh, swqyiudexb - yybzlypior)
-
19 Feb 2025
Phase 2
20
miiwiqvxda(otufdzswph) = bqegptocxf qskhddfpgy (yevtecizzt, vjgxmrwxyg - hwlshutlty)
-
19 Feb 2025
Phase 1/2
-
mmkrmmzjam(dvrzeicuoc) = uifpebferq syfdeuyrdm (tfmexnqchu, 10 - 31)
Positive
13 Feb 2025
Lenvatinib 20 mg PO QD + Belzutifan 120 mg PO QD
mmkrmmzjam(dvrzeicuoc) = envuczivdb syfdeuyrdm (tfmexnqchu, 34 - 60)
Not Applicable
33
nbsohtivjp(jlmoyvjeoe) = smqvfkgije labpfffavm (dcuhlmrvdr, 31 - 66)
Positive
13 Feb 2025
Phase 3
886
enfortumab vedotin in combination with pembrolizumab
ionxavzokn(bttatlmtzh) = mdoqavwsdq dnacogzfyq (ydcgctknpj, 10.4 - 16.6)
Positive
13 Feb 2025
chemotherapy
ionxavzokn(bttatlmtzh) = lboesqpsel dnacogzfyq (ydcgctknpj, 6.2 - 6.5)
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Regulation

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