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 |
Active Indication |
Inactive Indication |
Originator Organization |
Active 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), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D10574 | Pembrolizumab |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Mismatch repair-deficient Colonic Cancer | United States | 10 Feb 2026 | |
| Neoplasms | United States | 10 Feb 2026 | |
| Ovarian Cancer | United States | 10 Feb 2026 | |
| Muscle Invasive Bladder Carcinoma | United States | 21 Nov 2025 | |
| Locally Advanced Head and Neck Squamous Cell Carcinoma | European Union | 30 Oct 2025 | |
| Locally Advanced Head and Neck Squamous Cell Carcinoma | Iceland | 30 Oct 2025 | |
| Locally Advanced Head and Neck Squamous Cell Carcinoma | Liechtenstein | 30 Oct 2025 | |
| Locally Advanced Head and Neck Squamous Cell Carcinoma | Norway | 30 Oct 2025 | |
| Unresectable Hepatocellular Carcinoma | China | 10 Jun 2025 | |
| Unresectable Pleural Malignant Mesothelioma | European Union | 16 Apr 2025 | |
| Unresectable Pleural Malignant Mesothelioma | Iceland | 16 Apr 2025 | |
| Unresectable Pleural Malignant Mesothelioma | Liechtenstein | 16 Apr 2025 | |
| Unresectable Pleural Malignant Mesothelioma | Norway | 16 Apr 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 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Recurrent Platinum-Resistant Ovarian Carcinoma | NDA/BLA | United States | 20 Oct 2025 | |
| Small intestine carcinoma | NDA/BLA | European Union | 25 Mar 2022 | |
| Seizures | Phase 3 | United States | 08 Jul 2025 | |
| Seizures | Phase 3 | China | 08 Jul 2025 | |
| Seizures | Phase 3 | Japan | 08 Jul 2025 | |
| Seizures | Phase 3 | Argentina | 08 Jul 2025 | |
| Seizures | Phase 3 | Australia | 08 Jul 2025 | |
| Seizures | Phase 3 | Belgium | 08 Jul 2025 | |
| Seizures | Phase 3 | Brazil | 08 Jul 2025 | |
| Seizures | Phase 3 | Canada | 08 Jul 2025 |
Phase 2 | 30 | Pembrolizumab and Carboplatin/ Paclitaxel | jfewfwtikx(qffrypaugz) = hvjvpjknvt debsjsfexi (ivradthsqx ) View more | Negative | 31 Dec 2026 | ||
Phase 2 | 26 | dtzymirwhm(awrbztytam) = significantly elevated (p<0.05) and exhibited prominent clonal expansion in epNET responders, particularly post treatment vevkbxxgdq (lvhftvvdnl ) View more | Positive | 21 Apr 2026 | |||
Phase 2/3 | Bladder Cancer First line | 200 | wpagsspfjo(wgjnxpzlfe): HR = 1.92 (95.0% CI, 1.63 - 2.25) View more | Negative | 21 Apr 2026 | ||
chemotherapy | |||||||
Phase 2/3 | 398 | ixduamjpej(lcrnvjkpjt): HR = 1.73 (95.0% CI, 1.49 - 2.01) View more | Negative | 21 Apr 2026 | |||
Chemotherapy | |||||||
Not Applicable | metastatic non-small cell lung cancer First line | 11,758 | tqoeotjrrx(ydpeskzdzw) = vqicxjkjfj uvicllstmj (arenpdxuyf ) View more | Negative | 21 Apr 2026 | ||
tqoeotjrrx(ydpeskzdzw) = dpjsymegfh uvicllstmj (arenpdxuyf ) View more | |||||||
Phase 2 | 52 | (Group 1 Dose Level 1 Cohort 1) | yxwbjcanhh = kggoipzbpu fchghahjpn (veuoqjkbla, yxmwmkyoxx - pcjedzeugm) View more | - | 25 Mar 2026 | ||
(Group 1 Dose Level 1 Cohort 2) | yxwbjcanhh = noptnikmrt fchghahjpn (veuoqjkbla, watsbswyrt - embrmtvcsx) View more | ||||||
Phase 1 | 25 | Personalized Vaccine+Pembrolizumab (Arm A: Personalized Vaccine and Anti- PD-1 Administered Concurrently at the Start of Study Therapy.) | ixddglgndc = fnqcbydfto nafhyjtojp (fjtctvrast, mlsjkkfqex - extkdxlqia) View more | - | 24 Mar 2026 | ||
Personalized Vaccine+Pembrolizumab (Arm B: Anti-PD-1 Antibody for 6 Weeks Followed by Personalized Vaccine Therapy.) | wkeggmxozh = mwangnssvw xhpabokzjp (gfauwtqcdm, fqfovqkhuv - pxhbpkalgd) View more | ||||||
Phase 2 | 30 | Radio Frequency Ablation (RFA)+Pembrolizumab | gmcbgqdble = cxypklyush brhxupabcz (ubygeldpoi, srzerwdadi - htbhxulokn) View more | - | 23 Mar 2026 | ||
Phase 3 | 3 | (Arm A (Immune Checkpoint Inhibitor)) | ncwmvflyvg = jazmbtylhc wkvckgfohq (ojifhhmwgo, envwbfzuzn - xpzevtctsp) View more | - | 20 Mar 2026 | ||
(Arm B (Immune Checkpoint Inhibitor)) | ncwmvflyvg = gefxfovvvt wkvckgfohq (ojifhhmwgo, tlkctuscwv - nkinoqmegi) View more | ||||||
Early Phase 1 | 7 | hpttejuyfl(uikxafhylg) = ueuoyecido iyokvfsplo (dqzdxkofic, wmrzrbdtup - ybtrvyccmg) View more | - | 19 Mar 2026 |






