Keytruda (pembrolizumab) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Merck Sharp & Dohme Corp. Keytruda (pembrolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s096lbl.pdf. Revised March 2021. Accessed October 6, 2026.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication

Statements

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.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	PD-L1 (CPS) >= 10	Adenocarcinoma of the Gastroesophageal Junction	Pembrolizumab
FDA (1)	PD-L1 (CPS) >= 10	Esophageal Adenocarcinoma	Pembrolizumab