Regulatory approval

Published by the Food and Drug Administration. Approved

KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS >=10) as determined by an FDA-approved test.

This is written in the approval document.

Citation

Merck Sharp & Dohme Corp. Keytruda (pembrolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514Orig1s186lbl.pdf. Revised February 2026. Accessed March 2, 2026.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	PD-L1 (CPS) >= 10	Adenocarcinoma of the Gastroesophageal Junction	Pembrolizumab
FDA (2)	PD-L1 (CPS) >= 10	Esophageal Adenocarcinoma	Pembrolizumab

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals