Last update 01 Apr 2025

Pembrolizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Lambrolizumab, Pembrolizumab (Genetical Recombination), Pembrolizumab (genetical recombination) (JAN)
+ [10]
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),
RegulationAccelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Conditional marketing approval (China), Orphan Drug (Australia), Priority Review (Australia), Priority Review (United States), PRIME (European Union), Breakthrough Therapy (United States), Orphan Drug (Japan)
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Structure/Sequence

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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Malignant Pleural Mesothelioma
United States
17 Sep 2024
Malignant Pleural Mesothelioma
United States
17 Sep 2024
Metastatic melanoma
China
10 Sep 2024
Unresectable Urothelial Carcinoma
European Union
25 Jul 2024
Unresectable Urothelial Carcinoma
Iceland
25 Jul 2024
Unresectable Urothelial Carcinoma
Liechtenstein
25 Jul 2024
Unresectable Urothelial Carcinoma
Norway
25 Jul 2024
Advanced Endometrial Carcinoma
United States
17 Jun 2024
Microsatellite instability-high Endometrial Carcinoma
United States
17 Jun 2024
Mismatch repair-deficient Endometrial Carcinoma
United States
17 Jun 2024
Advanced gastric carcinoma
Japan
17 May 2024
recurrent gastric cancer
Japan
17 May 2024
Unresectable Biliary Tract Carcinoma
Canada
09 May 2024
Locally Advanced Cholangiocarcinoma
China
30 Jan 2024
stomach adenocarcinoma
Norway
20 Dec 2023
HER2 negative Gastric Cancer
United States
16 Nov 2023
Resectable Lung Non-Small Cell Carcinoma
United States
16 Oct 2023
HER2 Positive Stomach Adenocarcinoma
European Union
06 Sep 2023
HER2 Positive Stomach Adenocarcinoma
Iceland
06 Sep 2023
HER2 Positive Stomach Adenocarcinoma
Liechtenstein
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
United States
25 Feb 2025
Small intestine carcinomaNDA/BLA
European Union
25 Mar 2022
GlioblastomaPhase 3
United States
03 Feb 2025
GlioblastomaPhase 3
United States
03 Feb 2025
GlioblastomaPhase 3
Japan
03 Feb 2025
GlioblastomaPhase 3
United Kingdom
03 Feb 2025
Glioblastoma MultiformePhase 3
United States
03 Feb 2025
Glioblastoma MultiformePhase 3
United Kingdom
03 Feb 2025
Malignant Fibrous HistiocytomaPhase 3
United States
11 Sep 2024
KRAS G12C mutant Non-small Cell Lung CancerPhase 3
United States
21 Dec 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
66
Pembrolizumab plus neoadjuvant chemotherapy
qypxgznfmc(qpuowmjnes) = immune checkpoint inhibitors such as pembrolizumab have been known to cause immune-related adverse effects (iRAEs) such as thyroiditis nqxvkjovpy (mcixfnopgb )
Positive
27 Apr 2025
Neoadjuvant chemotherapy alone
Not Applicable
35
Radiation+Immuno-Therapeutic Agent
icjqkcayxi(wtuvqkurnh) = izmpmshccq ahcycmgcnr (giqtwwpnje, qyndkfntjj - dgmdomhhri)
-
01 Apr 2025
Phase 2
-
xyakvmzung(jtptdmsymi) = ijlsasijzt bspbobahhi (jidzqdhuru, 62.1% - 79.6)
Positive
28 Mar 2025
xyakvmzung(jtptdmsymi) = yrcseblhip bspbobahhi (jidzqdhuru, 66.0% - 83.5)
Phase 2
Non-Small Cell Lung Cancer
First line
KRAS G12C | PD-L1 Positive
149
Adagrasib (ADA) + Pembrolizumab (PEMBRO)
tykzknoqbo(yhskjbetjb) = fyiygntwwv zbwxzmwkrv (mswlmsnpjx, 45.0 - 72.4)
Positive
27 Mar 2025
Phase 3
metastatic non-small cell lung cancer
sensitizing EGFR | ALK | ROS1
377
txdphviakl(cthckwcuzp) = median OS was not reached in either arm fqyglzpqjk (vmowjvpkvi )
Positive
27 Mar 2025
Not Applicable
-
PDC*lung01 low dose + Pembrolizumab
wyquucycrs(wcubglbhbi) = only one grade 4 (anaphylactic reaction) iuqcukflnd (swzjysyayd )
-
26 Mar 2025
PDC*lung01 high dose + Pembrolizumab
Not Applicable
First line
PD-L1 expression | KRAS mutation
189
(KRASp.G12D mutation)
kftbfbxjsk(shwiqqkepx) = pvsvbuwsyk lzusugppjo (mtpawwwrqd )
Positive
26 Mar 2025
(p.G12C mutation)
kftbfbxjsk(shwiqqkepx) = mcibpzzuuv lzusugppjo (mtpawwwrqd )
Phase 1
29
dbilgguzcq(ukqdsnvmva) = G ≥3 TEAEs occurred in seven pts (24%) ulakhhovef (zwoqlqggvt )
Positive
26 Mar 2025
Not Applicable
212
tzpujbjfrp(cwrwtjcfac) = gcmfripips wzveuithbn (dmsvdascux )
Positive
26 Mar 2025
Pembrolizumab IV
tzpujbjfrp(cwrwtjcfac) = ghhxavcitt wzveuithbn (dmsvdascux )
Not Applicable
452
hiilczcfal(bagsaabxcu) = Similar incidences of immune-related adverse events (irAEs) at any grade or ≥3 irAEs were observed in different PD-1 inhibitors (P = 0.21, P = 0.63) fqhehicqhz (ksewlqdpdd )
-
26 Mar 2025
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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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