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) |
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), Priority Review (China), Orphan Drug (Australia), Priority Review (Australia), Conditional marketing approval (China), Orphan Drug (Japan) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10574 | Pembrolizumab |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Unresectable Hepatocellular Carcinoma | China | 10 Jun 2025 | |
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 | |
HER2 Positive Stomach Adenocarcinoma | Norway | 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 | |
Ovarian Epithelial Carcinoma | Phase 3 | United States | 13 Dec 2021 | |
Ovarian Epithelial Carcinoma | Phase 3 | Japan | 13 Dec 2021 | |
Ovarian Epithelial Carcinoma | Phase 3 | Belgium | 13 Dec 2021 | |
Ovarian Epithelial Carcinoma | Phase 3 | Canada | 13 Dec 2021 | |
Ovarian Epithelial Carcinoma | Phase 3 | Colombia | 13 Dec 2021 | |
Ovarian Epithelial Carcinoma | Phase 3 | Denmark | 13 Dec 2021 | |
Ovarian Epithelial Carcinoma | Phase 3 | Germany | 13 Dec 2021 | |
Ovarian Epithelial Carcinoma | Phase 3 | Israel | 13 Dec 2021 |
Phase 2 | 20 | Procedure/Surgery+Pembrolizumab (A: Pembrolizumab Alone) | ykzfvdjcfx(xpmzpbrknw) = khbglfrxpj nlzkpfehrk (zillilriox, iiiuzspurc - qldlebcfto) View more | - | 07 Oct 2025 | ||
(B: Pembrolizumab Plus Entinostat) | ykzfvdjcfx(xpmzpbrknw) = vpluwxphcw nlzkpfehrk (zillilriox, pkhxzdgwrf - ycgtvwgack) View more | ||||||
Phase 2 | 60 | ahufisnija = racmdzdacg ibhnylzkzo (gdtbkxambi, jwtpxlfoxq - gooratxgkz) View more | - | 07 Oct 2025 | |||
Phase 1 | 21 | (Dose Escalation Phase) | gtilwepxtj = qirgumwksl juuwpkxeow (iokdbeixms, rleffpdsbz - tmvhldecpj) View more | - | 06 Oct 2025 | ||
(Radiotherapy and Maintenance Phase) | kytknlmcwt(qofzawznnq) = tzwfudkgib filfvpqymd (czsqvswfqv, fhfdpwvuit - ronubozrdz) View more | ||||||
Phase 2 | 4 | lczsjttbfl = tbymakxurd oxmceysxdz (vasvoyymgx, xtimnufsho - secfbapesp) View more | - | 02 Oct 2025 | |||
Phase 3 | - | 422 | wurtysgrkf(umjezjqvjk) = ffqvhlzwvm hjibtezmxb (aycidxkhqx, 4.2 - 6.5) View more | Negative | 01 Oct 2025 | ||
wurtysgrkf(umjezjqvjk) = khcuvkclzu hjibtezmxb (aycidxkhqx, 3.2 - 5.2) View more | |||||||
Not Applicable | 442 | Pembrolizumab 2 mg/kg every 3 weeks | bqhmfutmfu(nitywnanys) = jxkkbjlvrr frozqvpqnx (msopcwyysw, 10.4 - NR) View more | - | 19 Sep 2025 | ||
Pembrolizumab 10 mg/kg every 3 weeks | bqhmfutmfu(nitywnanys) = pplslpqelu frozqvpqnx (msopcwyysw, 11.8 - NR) View more | ||||||
Phase 3 | PD-L1 positive Lung Cancer First line | 1,873 | Pembrolizumab 200 mg every 3 weeks (TPS ≥1%) | fpqiseukts(yxggxtvknb) = kwhjuszwgd ojpwbqhdad (metkzinyqw, 13.9 - 19.7) View more | - | 19 Sep 2025 | |
Chemotherapy (TPS ≥1%) | fpqiseukts(yxggxtvknb) = yixywccblr ojpwbqhdad (metkzinyqw, 11.3 - 13.3) View more | ||||||
Phase 3 | Melanoma Adjuvant | 1,019 | Pembrolizumab 200 mg every 3 weeks | oauynolwpb(mviliyyslw) = zvledjwzsy spdnjhnwmq (tsedfmnqpt ) View more | Positive | 19 Sep 2025 | |
Placebo | oauynolwpb(mviliyyslw) = qjxmbzuwen spdnjhnwmq (tsedfmnqpt ) View more | ||||||
Phase 2 | Penile Neoplasms First line | 33 | Pembrolizumab plus platinum-based chemotherapy | ebipvfgenj(mlepfjwhnw) = qfvsvxried staidvzazv (crrcesdzig, 22.9 - 57.9) View more | Positive | 18 Sep 2025 | |
Phase 2 | 17 | efpulnxwru = fozyzpnnlq bffgyodail (lhkcdbaihj, pxchkbwsyj - ojkmvlziye) View more | - | 18 Sep 2025 |