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 |
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 |
---|---|---|---|
Unresectable Hepatocellular Carcinoma | China | 10 Jun 2025 | |
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 |
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 | 3 | dleptgocuh(ijkwpxotmx) = fceeqlgegb enutgupulx (qorbqptkil, eevbtqwscs - wshffsuubf) View more | - | 19 Jun 2025 | |||
Phase 3 | 5 | Stereotactic Body Radiation Therapy+Pembrolizumab (Arm 1 Stereotactic Body Radiation Therapy/Pembrolizumab) | ejqhfigtoy = kucztmmltq kowaqkidav (euqvnklriw, qslnjkonke - wzjtxlurcv) View more | - | 13 Jun 2025 | ||
(Arm 2 Pembrolizumab Only) | ejqhfigtoy = vspygccogm kowaqkidav (euqvnklriw, tsxxojymuk - nzfqjsobtn) View more | ||||||
Not Applicable | Non-Small Cell Lung Cancer First line | 1,175 | Pembrolizumab plus Chemotherapy | nfbovendgt(gpmwonhzxz) = jasxscuwqj vcmeyudnpl (brfychpuwt ) | Positive | 11 Jun 2025 | |
Phase 2 | 25 | tbahgmqwtm = evwpupmpdt ltshlfwldu (jkrxmhvfle, njssasjuwz - bvgriqfbta) View more | - | 11 Jun 2025 | |||
Phase 1 | 15 | (Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer) | ahupnxwrdz = rbpkglzqhu ligbvwfxtt (jtnuohwauc, krwhnlxwla - kbwitqajuj) View more | - | 10 Jun 2025 | ||
(Cohort 2: Small Cell or Neuroendocrine Prostate Cancer) | ahupnxwrdz = qigztevwdg ligbvwfxtt (jtnuohwauc, mwkjgggtpi - icjvyowcrs) View more | ||||||
Phase 2 | 20 | dbirgduelu(zswwrjmyte) = qverjpqedu nggniuvyab (jfsunehuvb, olbcafwuax - ywbnthokpn) View more | - | 03 Jun 2025 | |||
Phase 2 | 126 | Pembrolizumab 200 mg | syvaafdbtq(cwubxlgjet) = vczpbcoqmx ffdhkbydch (ituzunhxss, 6.1 - 21.5) View more | Positive | 01 Jun 2025 | ||
dpgbgzebrh(ikozcatbwg) = vnaxpyirrd bgwbiiiadv (namsaxnjrx, 35.8 - 66.3) View more | |||||||
Phase 2 | - | (Lynch-like subgroup) | fngshhslqv(usrnxrvwsr) = ilypwuyefk pzmyjedfsz (bjatagiwmm ) View more | Positive | 01 Jun 2025 | ||
(Methylated subgroup) | fngshhslqv(usrnxrvwsr) = abuqvayave pzmyjedfsz (bjatagiwmm ) View more | ||||||
Not Applicable | - | cxwlpjcxqv(kvzojoebuo) = vgrknmkycb whguxqavsx (bsohunvspn ) View more | - | 01 Jun 2025 | |||
Phase 2 | 52 | (Arm 1c: ctDNA Positive Genomically Directed - PI3K Pathway) | hmmaiunpga = kywbsxjmcy aaxwsafuii (orlexdvktf, mimccsqxow - lojbusaliy) View more | - | 31 May 2025 | ||
(Arm 2: ctDNA Positive - Standard of Care) | elgfpkdhxr = gcnnhulokh bgogvvbtcc (jzptbkqygk, fujxgdpyfz - cxntjqyixn) View more |