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Pembrolizumab · Keytruda, MK-3475

Monoclonal antibody · Antagonist of PD-1 (PDCD1) · developed by Merck Sharp Dohme

Approved FDA, Sep 2014

MRK Developer

6 Registered trials

What is Pembrolizumab?

Pembrolizumab is a humanized monoclonal antibody that binds to PD-1 on T cells and blocks interaction with its ligands PD-L1 and PD-L2, releasing inhibition of the anti-tumor immune response.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Keytruda, MK-3475, SCH-900475, Pembrolizuma
Drug type: Monoclonal antibody
Targets: PD-1 (PDCD1), PD-L1 (CD274) (secondary target), PD-L2 (PDCD1LG2) (secondary target)
Mechanism: Antagonist of PD-1 (PDCD1)
Pathways: T-cell activation, anti-tumor immune response
Therapy area: Oncology
Developer: Merck Sharp Dohme (MRK)
Also in trials of: NGNE
FDA status: Approved as Keytruda (September 4, 2014), BLA125514 · FDA label
UNII: DPT0O3T46P

✅ FDA-approved uses

Unresectable or metastatic melanoma
Adjuvant treatment of Stage IIB, IIC, or III melanoma following complete resection
Metastatic nonsquamous NSCLC (first-line, in combination with pemetrexed and platinum chemotherapy)
Metastatic squamous NSCLC (first-line, in combination with carboplatin and paclitaxel or paclitaxel protein-bound)
NSCLC expressing PD-L1 (TPS ≥1%), Stage III or metastatic (first-line, single agent)
Metastatic NSCLC with PD-L1 expression (TPS ≥1%) and disease progression after platinum-containing chemotherapy
Resectable NSCLC (neoadjuvant and adjuvant treatment)
Malignant Pleural Mesothelioma (first-line, in combination with pemetrexed and platinum chemotherapy)

From the indications section of the FDA label (version of Jul 10, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT07216703	Phase 3	Cervical Cancer	Recruiting	MRK
NCT06788912	Phase 2	Lung Neoplasm Malignant	Active not recruiting	MRK
NCT06110793	Phase 1/2	Metastatic Breast Cancer	Active not recruiting	MRK
NCT05482893	Phase 1/2	Gastric or Gastroesophageal Junction Adenocarcinoma	Recruiting	MRK
NCT05007106	Phase 2	Uterine Cervical Neoplasms	Completed	MRK
NCT04659629	Phase 1	Solid Tumor	Completed	NGNE

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Biliary Tract Cancer (BTC)Cervical CancerColorectal CancerGastric or Gastroesophageal Junction AdenocarcinomaLung Neoplasm MalignantMetastatic Breast CancerPancreatic Ductal AdenocarcinomaAdvanced Solid TumorCholangiocarcinomaEndometrial NeoplasmsEsophageal NeoplasmsGallbladder NeoplasmsHepatocellular CarcinomaOvarian Neoplasms

Other drugs acting on PDCD1

Berahyaluronidase Alfa and Pembrolizumab FDA approved Nivolumab FDA approved Toripalimab FDA approved Atigotatug/Nivolumab Phase 1 Balstilimab Phase 2/3 BPT567 Phase 1 Budigalimab Phase 2/3 Cadonilimab Early Phase 1 CDX-585 Phase 1 CTX-8371 Phase 1 Geptanolimab Phase 1/2 Ivonescimab Phase 3

More from Merck Sharp Dohme

BCG Live FDA approved Belzutifan FDA approved Berahyaluronidase Alfa FDA approved Berahyaluronidase Alfa and Pembrolizumab FDA approved Enlicitide FDA approved Ensifentrine FDA approved Letermovir FDA approved Probenecid FDA approved Alimatravir Phase 2 Bomedemstat Phase 2/3 Calderasib Phase 3 Favezelimab Phase 1/2

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the MRK page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z