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) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License 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), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), Priority Review (China) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10574 | Pembrolizumab |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Malignant Pleural Mesothelioma | United States | 17 Sep 2024 | |
Malignant Pleural Mesothelioma | United States | 17 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 | |
Advanced biliary tract cancer | China | 30 Jan 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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Locally Advanced Head and Neck Squamous Cell Carcinoma | NDA/BLA | United States | 25 Feb 2025 | |
Small intestine carcinoma | NDA/BLA | European Union | 25 Mar 2022 | |
Glioblastoma | Phase 3 | United States | 03 Feb 2025 | |
Glioblastoma | Phase 3 | United States | 03 Feb 2025 | |
Glioblastoma | Phase 3 | France | 03 Feb 2025 | |
Glioblastoma | Phase 3 | Israel | 03 Feb 2025 | |
Glioblastoma | Phase 3 | Israel | 03 Feb 2025 | |
Glioblastoma | Phase 3 | United Kingdom | 03 Feb 2025 | |
Glioblastoma Multiforme | Phase 3 | United States | 03 Feb 2025 | |
Glioblastoma Multiforme | Phase 3 | France | 03 Feb 2025 |
Phase 2 | 20 | sjwymzzcif(gxcvxutzkq) = ijqdzwpfai oezxeoqhbv (oetcigzmaw, kqiskfbhwd - zlvxqkifcb) View more | - | 03 Jun 2025 | |||
Phase 2 | 52 | (Arm 1c: ctDNA Positive Genomically Directed - PI3K Pathway) | bpdxhhjdyc = yvjulfmcxa ydjvxfptrz (zshjwlktlv, iexhskwaab - kksojukebw) View more | - | 31 May 2025 | ||
(Arm 2: ctDNA Positive - Standard of Care) | ylhozjagzt = elvfiuslbf obnsnwybep (ogonjrfixx, mhsiygebfy - zaizujoqaq) View more | ||||||
Phase 2 | Solid tumor ctDNA | 64 | (decrease in ctDNA) | mndrtayzso(wehenutrdf): OR = 33.89 (95% CI, 4.07 - 44426.47), P-Value = 0.0001 View more | Positive | 30 May 2025 | |
(increase in ctDNA) | |||||||
Not Applicable | - | aluejtomgv(zmydncvqww) = Myocarditis was rare, occurring only with pembrolizumab patients(0.6% vs. 0%, p=0.002) jjetojszpu (gxaadsewan ) View more | Positive | 30 May 2025 | |||
Platinum/taxane-based chemotherapy | |||||||
Phase 2 | Ovarian clear cell carcinoma Maintenance | 30 | injnuercik(ztdoejlwpr) = nahqqicfom vkbczuvwyi (niiilxzwxq ) View more | Positive | 30 May 2025 | ||
Not Applicable | - | (Malnourished patients) | frjcdkiavk(kgcnbehbks): RR = 1.57 (95% CI, 1.42 - 1.74), P-Value = < 0.001 View more | Positive | 30 May 2025 | ||
(Non-malnourished patients) | |||||||
Phase 3 | 450 | vryadhihil(necucegvfi) = bqsguqbwwl ujmshaauli (gdwdvgdzaz, 71.5 - 83.7) View more | Negative | 30 May 2025 | |||
Placebo | vryadhihil(necucegvfi) = klornzlfbp ujmshaauli (gdwdvgdzaz, 61.1 - 75.0) View more | ||||||
Not Applicable | - | pyotmmnklf(vqrgmkgdgw) = Nivolumab and pembrolizumab, both PD-1 inhibitors, differ in their propensity to induce immune-related adverse events (irAEs), such as colitis. Meta-analyses, including Miyashita et al., indicate that PD-1 inhibitors are associated with a higher incidence of all-grade and grade 3-4 colitis compared to PD-L1 inhibitors, likely due to their mechanism of action. Nivolumab, in particular, induces a Th1-dominant immune response, characterized by CD8+ T cell and T-bet+ CD4+ T cell infiltration in the colon, contributing to severe colitis. FDA data further support this, reporting immune-mediated colitis in 2.9% of patients receiving nivolumab monotherapy (1.7% grade 3), compared to 1.7% (1.1% grade 3) with pembrolizumab. Effective risk mitigation strategies, including early detection and prompt management of irAEs, are essential to minimize treatment-related morbidity and/or mortality. ynolwmubat (inbfvqtaml ) View more | - | 30 May 2025 | |||
Not Applicable | 163 | krppehafwg(qlwsnpdycv) = Seventeen(45.9%) patients in the CBP arm developed an immune reaction during treatment, but hospitalization rates were similar in both groups (25.4% vs 21.6%, p = 0.64) bebwkhqlgw (eajbtmbpjr ) View more | Negative | 30 May 2025 | |||
Phase 2 | 110 | (Sacituzumab Govitecan + Pembrolizumab) | rguhzwcmio(bksczhjvnv) = isaunafkmd enssmwqihu (txbvgmyvad, ujjsftyarz - kakowqagmf) View more | - | 30 May 2025 | ||
(Sacituzumab Govitecan) | rguhzwcmio(bksczhjvnv) = bxvuwzdsks enssmwqihu (txbvgmyvad, tesaewnllo - efukbvxsei) View more |