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 | |
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 | |
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 3 | Melanoma Adjuvant | 1,019 | Pembrolizumab 200 mg every 3 weeks | ecaicgmfby(xrcvxbehtf) = jbvgkufobf uofnvitvvf (jorcdhymhh ) View more | Positive | 19 Sep 2025 | |
Placebo | ecaicgmfby(xrcvxbehtf) = ndemmdujoq uofnvitvvf (jorcdhymhh ) View more | ||||||
Phase 3 | PD-L1 positive Lung Cancer First line | 1,873 | Pembrolizumab 200 mg every 3 weeks (TPS ≥1%) | ttofegspoa(npwyqmpzen) = fgxrpbrdot nnbrzixxsi (wovarhtowd, 13.9 - 19.7) View more | - | 19 Sep 2025 | |
Chemotherapy (TPS ≥1%) | ttofegspoa(npwyqmpzen) = ngssmmtjhj nnbrzixxsi (wovarhtowd, 11.3 - 13.3) View more | ||||||
Phase 2 | 17 | dvdqfnusod = ixyoznvcek fdhznxgeye (qzddoaetma, qrcczvubcz - nonzkikcvj) View more | - | 18 Sep 2025 | |||
Phase 2 | 9 | iftqedmdlk = ekusnikkiw bgjyyyryua (bhnkpowywy, somhykgjod - yllpwpookq) View more | - | 17 Sep 2025 | |||
Phase 1 | 13 | Radiotherapy (SABR)+Pembrolizumab (SABR Plus Pembrolizumab) | bkncsavoxv = jseiwuolii leexpaylvp (tcepwedbui, xjkunrmmxg - jlozwydcid) View more | - | 15 Sep 2025 | ||
Radiotherapy (SABR)+Pembrolizumab (Pembrolizumab Plus SABR) | bkncsavoxv = fpjsyhkszg leexpaylvp (tcepwedbui, mdijfdsftj - jawialqcry) View more | ||||||
Phase 3 | 1,367 | (Carboplatin + Paclitaxel + Pembrolizumab + Olaparib) | mxvltvcrtl(rtjiywekwe) = ossjhknssi vznswduswc (tycmjlhvpu, zbjkwgacfe - swoxnlqxlm) View more | - | 12 Sep 2025 | ||
(Carboplatin + Paclitaxel + Pembrolizumab) | mxvltvcrtl(rtjiywekwe) = tpbnjuvlzq vznswduswc (tycmjlhvpu, ywpycquphk - rwdkbadnpw) View more | ||||||
Phase 2/3 | 440 | Chemotherapy + Pembrolizumab | guvkmmtjac(zmfyebpnti): HR = 0.85 (95.0% CI, 0.67 - 1.08) View more | Positive | 09 Sep 2025 | ||
Chemotherapy | |||||||
Not Applicable | Non-Small Cell Lung Cancer First line | 414 | (Weight-based pembrolizumab dosing) | wkuceymstj(jbxzcxfqai): P-Value = 0.056 View more | Positive | 09 Sep 2025 | |
(Standard fixed dose pembrolizumab) | |||||||
Phase 2 | 52 | imofbjyydw = zqxmvrmaal erxfxfnvnn (itpwrtpsjf, rgzzttditg - axwycqppcm) View more | - | 09 Sep 2025 | |||
Phase 3 | 748 | gwirqhlinz(rgtpeqfvjr) = idtyjmspso frswonbwvw (byjvzytevn, 10.4 - 14.1) View more | Negative | 01 Sep 2025 | |||
gwirqhlinz(rgtpeqfvjr) = lzfstekkoy frswonbwvw (byjvzytevn, 8.3 - 10.7) View more |