Drug profile · INN
pembrolizumab
KEYTRUDA
pembrolizumab (KEYTRUDA) is a programmed cell death protein 1 inhibitor. Associated with Merck KGaA, Darmstadt, Germany. Route of administration: injection. Current US regulatory status: approved.
Drug details — pembrolizumab
- US status
- approved
- Class
- Antineoplastic and immunomodulating agents (L01)
- Route
- INJECTION
- Patents
- 20
- Programs
- 341
- Data quality
- 0.84
Quick answer
pembrolizumab (KEYTRUDA) is a programmed cell death protein 1 inhibitor. Associated with Merck KGaA, Darmstadt, Germany. Route of administration: injection. Current US regulatory status: approved.
Key facts
Mechanism of action
Programmed cell death protein 1 inhibitor
Primary target: Programmed cell death protein 1
Approval history
| Authority | Status | Date |
|---|---|---|
| FDA | approved | — |
| EMA | approved | — |
| TGA | approved | — |
| PMDA | approved | — |
| NMPA | clinical trials | — |
Recent coverage
Medicare price rule could hit Keytruda and Opdivo subcutaneous launches
CMS is proposing a Medicare drug price rule that could shape the outlook for subcutaneous Keytruda and Opdivo. The products are expected to be eligible for selection in the 2027 negotiation round for IPAY 2029.
FDA approves belzutifan plus pembrolizumab for adjuvant RCC
The FDA approved belzutifan plus pembrolizumab as adjuvant therapy for clear cell renal cell carcinoma at high risk of recurrence after nephrectomy. The catalyst is based on phase 3 LITESPARK-022 data and adds another regulatory milestone for belzutifan.
FDA priority review advances belzutifan plus pembrolizumab in adjuvant RCC
The FDA granted priority review to supplemental applications for belzutifan plus pembrolizumab in adjuvant renal cell carcinoma. The move extends Merck’s renal cancer catalyst path after evidence showed improved disease-free survival versus pembrolizumab alone.
Merck and Gilead report mixed outcomes in lung cancer and HIV studies
Merck Gilead report mixed outcomes in key lung cancer and HIV studies: a Phase 3 Trodelvy plus KEYTRUDA lung cancer trial was halted, while two Phase 3 HIV studies for islatravir/lenacapavir reported positive topline results. This plan focuses on the business and clinical implications for analysts and BD teams.
Congress & event coverage
- PresentationASCO 2026
Pipeline programs
Related & competitor drugs
Related patents
-
WO 2025252204
DISPERSIONS SOLIDES AMORPHES D'UN INHIBITEUR DE BRAF
granted -
WO 2025232885
PROCÉDÉ DE PRÉPARATION D'UN AGENT DE DÉGRADATION DE LA TYROSINE KINASE DE BRUTON
granted -
WO 2025218772
FORMES SOLIDES COMPRENANT UN AGENT DE DÉGRADATION DE TYROSINE KINASE DE BRUTON ET LEURS UTILISATIONS
granted -
WO 2025214466
CONJUGUÉS DE PYRROLOBENZODIAZÉPINE CIBLÉS
granted -
WO 2025201453
COMPOSÉS MACROCYCLIQUES UTILISÉS EN TANT QU'INHIBITEURS DE RAS
granted -
US 12404328
Multi-specific binding proteins and methods of use thereof
granted -
US 12404497
Uses and methods for oncolytic virus targeting of IL-4/IL-13 and fusions thereof
granted -
WO 2025168081
TRAITEMENT D'UN TROUBLE PROLIFÉRATIF DES LYMPHOCYTES B AVEC UN COMPOSÉ ACTIVATEUR DE DÉGRADATION CHIMÉRIQUE
granted -
WO 2025168072
COMPOSÉS HÉTÉROCYCLIQUES, COMPOSITIONS ASSOCIÉES ET MÉTHODES DE TRAITEMENT ASSOCIÉS
granted -
WO 2025126115
DÉGRADATION DE L'IRAK4 PAR CONJUGAISON D'INHIBITEURS D'IRAK4 AVEC DES LIGANDS DE LIGASE E3 ET PROCÉDÉS D'UTILISATION
granted -
WO 2025108443
COMPOSÉS HÉTÉROCYCLIQUES ET COMPOSITIONS ASSOCIÉES, ET MÉTHODES DE TRAITEMENT CORRESPONDANTES
granted -
WO 2025078995
COMPOSÉS DE 6-(PYRIMIDIN-4-YL)QUINOLÉINE SUBSTITUÉS UTILISÉS EN TANT QU'INHIBITEURS DE KINASE DÉPENDANTE DE LA CYCLINE
granted -
WO 2025068985
DÉRIVÉS DE 1-(1-OXO-1,2-DIHYDROPHTALAZIN-6-YL)CYCLOALKYL-1-CARBOXAMIDE UTILISÉS EN TANT QU'INHIBITEURS COOPÉRATIFS DE MTA DE PRMT5
granted -
WO 2025062334
DÉRIVÉS DE 4-((5-(3-(4-(PYRIDIN-2-YL)CYCLOPENTYL)-1 H-PYRAZOL-3-YL)AMINO)-BENZÈNESULFONAMIDE ET COMPOSÉS SIMILAIRES UTILISÉS COMME INHIBITEURS DE CDK POUR LE TRAITEMENT DU CANCER
granted -
WO 2025052303
ARN CIRCULAIRE ET PROCÉDÉS DE PRÉPARATION ASSOCIÉS
granted -
WO 2025041076
COMPOSÉS BICYCLIQUES UTILISÉS EN TANT QU'INHIBITEURS DE CDK
granted -
US 12215135
PDL2 compounds
granted -
US 12194081
ARGINASE1 polypeptides
granted -
US 11911359
Stimulation of an immune response by cationic lipids
granted -
US 11702423
BRM targeting compounds and associated methods of use
granted
Frequently asked questions
What is pembrolizumab?
pembrolizumab (KEYTRUDA) is a programmed cell death protein 1 inhibitor. Associated with Merck KGaA, Darmstadt, Germany. Route of administration: injection. Current US regulatory status: approved.
What is the brand name for pembrolizumab?
KEYTRUDA is a marketed brand name for pembrolizumab. Check FDA Drugs@FDA for the current US label holder and prescribing information.
What is the US approval status of pembrolizumab?
pembrolizumab has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.