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/2022/125514s110lbl.pdf. Revised March 2022. 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 as a single agent, for the treatment of patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	pMMR	Endometrial Carcinoma	Pembrolizumab
FDA (1)	MSI-H	Endometrial Carcinoma	Pembrolizumab