Home
Drugs
Keytruda

Keytruda

Drug

Drug Profile

Keytruda is the brand name for pembrolizumab, a human PD-1 blocking antibody used across a broad range of cancers. It is approved in multiple tumor types and biomarker-defined settings, including melanoma, lung, head and neck, gastrointestinal, gynecologic, and urothelial cancers. The FDA first approved Keytruda in 2014.

Drug Class: PD-1 (programmed death receptor-1) blocking antibody
Approval Status: FDA approved; first approved September 4, 2014.
Mechanism of Action: Blocks programmed death receptor-1 (PD-1) signaling as an immune checkpoint inhibitor.

Brand Names

Keytruda

Indications

Melanoma
\Non-small cell lung cancer\
\Head and neck squamous cell cancer\
\Hodgkin lymphoma\
\Urothelial cancer\
\Gastric cancer\
\Esophageal cancer\
\Cervical cancer\
\Hepatocellular carcinoma\
\Renal cell carcinoma\
\Endometrial carcinoma\
\Biliary tract cancer\

Related News

FDA Approvals and Pipeline Expansion Drive Bladder Cancer Therapeutics Market Growth

Jun 23, 2026

The bladder cancer therapeutics market is expanding with recent FDA approvals including INLEXZO for NMIBC and a KEYTRUDA-Padvev combination for MIBC, while the NMIBC market reached approximately USD 3 billion in 2025 across seven major markets. Ferring reported record revenues exceeding €2.5 billion in 2025, driven by Adstiladrin as its second major growth driver. A robust pipeline of emerging therapies is expected to further transform the market through 2036.

AI and mRNA Cancer Vaccine Shows 49% Reduction in Melanoma Relapse at ASCO 2026

Jun 11, 2026

Long-term data from ASCO 2026 shows the personalized cancer vaccine Intismeran Autogene, combined with Keytruda, reduces recurrence or death risk by 49% in high-risk melanoma patients. Developed by MSD and Moderna, the vaccine uses AI to select neoantigens from a patient's tumor and mRNA technology to create a personalized treatment. The results signal a major advance for a field that had struggled for decades, spurring similar development efforts by other companies.

Merck/Gilead Discontinue Lung Cancer Trial as Pfizer, Roivant Report Pipeline Updates

Jun 09, 2026

Merck and Gilead discontinued a Phase 3 lung cancer trial due to lack of statistical significance, while Pfizer initiated a new Phase 1 trial and Roivant Sciences completed enrollment in its Phase 2 PHocus trial for pulmonary hypertension.

Oncology Drug Market Sees Strong Growth Amid Patent Cliffs and Novel Modality Shifts

Jun 05, 2026

Global oncology drug spending is projected to reach $467 billion by 2030, driven by novel modalities like ADCs and bispecifics, but growth will slow due to patent expirations for key drugs like Keytruda and Lynparza. R&D is shifting, with novel modalities accounting for 33% of clinical trials in 2025. The industry is also seeing broader innovation and investment, with new blockbuster contenders emerging across multiple therapeutic areas.

Pfizer Secures FDA Approvals for Two Cancer Drugs; Oncolytic Virus Pipeline Expands

Jun 01, 2026

The FDA has approved Pfizer's BRAFTOVI for BRAF V600E metastatic colorectal cancer and VEPPANU for ESR1 mutated breast cancer. The oncolytic virus cancer therapy pipeline expands with over 120 companies developing 125+ drugs. Positive late-stage data for other Pfizer oncology programs was also reported.

BioNTech Faces Mixed Analyst Views, FDA Fast-Track Designation, and Leadership Transition

May 26, 2026

BioNTech faces mixed analyst views as Bernstein initiates with a cautious Market Perform rating, while the company secures FDA Fast Track designation for BNT113 and prepares for a shareholder vote on capital restructuring and leadership transition.

FDA Approves AstraZeneca and Daiichi Sankyo's Datroway for First-Line Triple-Negative Breast Cancer

May 22, 2026

FDA approves AstraZeneca and Daiichi Sankyo's Datroway for first-line TNBC patients not eligible for PD-1/L1 inhibitors, based on Phase III TROPION-Breast02 data showing a 21% reduction in risk of death versus chemotherapy.

TuHURA gains FDA orphan drug designation for IFx-2.0 in cutaneous melanoma

May 17, 2026

TuHURA Biosciences said the FDA granted orphan drug designation to IFx-2.0 for stage IIB to stage IV cutaneous melanoma based on Phase 1 data. The company said its Phase 3 IFx-2.0 study in first-line Merkel cell carcinoma continues to enroll.

Microgravity drug research expands from ISS crystal studies to commercial manufacturing

May 13, 2026

Microgravity drug research is expanding from ISS crystal studies to commercial manufacturing efforts. New experiments and a Varda-United Therapeutics collaboration target improved drug stability, delivery and production.

European Biotechs Advance Next-Generation Immunotherapy Targets Beyond PD-1/PD-L1

May 01, 2026

European biotechs are exploring new immunotherapy targets beyond PD-1/PD-L1, including BTLA, TIGIT, and SLAMF6. Lund University researchers discovered a SLAMF6-mediated immune evasion mechanism. BioNTech and GenMab are advancing next-generation ICIs and bispecific antibodies through strategic partnerships.

Related Clinical Trials

NCT ID	Title	Status	Phase
NCT07475572	A Randomized, Double-Blind, Pharmacokinetic Similarity Study to Compare AVT32-DRL_PB With Keytruda® in Participants With Fully Resected Melanoma	NOT_YET_RECRUITING	PHASE1
NCT07388550	Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)	NOT_YET_RECRUITING	PHASE1
NCT07122687	IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer	RECRUITING	PHASE2
NCT06643117	Similar Efficacy, Safety, and Immunogenicity of FYB206 in Comparison to Keytruda as add-on to Chemotherapy in Patients With Non-squamous Non-small Cell Lung Cancer (NSCLC)	TERMINATED	PHASE3
NCT06551064	Assessment of PK Similarity of FYB206 in Comparison With Keytruda in Resected Stage II or III Melanoma Patients	ACTIVE_NOT_RECRUITING	PHASE1
NCT06472583	Preoperative Immunotherapy Combined With Stereotactic Radiation Therapy Boost in the Treatment of HER2-negative Breast Cancer	RECRUITING	PHASE2
NCT06400160	Clinical Trial of TB511 in Advanced Solid Tumors	NOT_YET_RECRUITING	PHASE1/PHASE2
NCT06348199	A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer	ACTIVE_NOT_RECRUITING	PHASE3
NCT05986331	Clinical Study of the Efficacy and Safety of BCD-201 and Keytruda in Subjects With Advanced Melanoma	UNKNOWN	PHASE3
NCT05849480	A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)	RECRUITING	PHASE1/PHASE2