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/2020/125514s088lbl.pdf. Revised November 2020. 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 in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS >=10) as determined by an FDA approved test.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	ER negative, HER2-negative, PD-L1 (CPS) >= 10, PR negative	Invasive Breast Carcinoma	Paclitaxel, Pembrolizumab
FDA (1)	ER negative, HER2-negative, PD-L1 (CPS) >= 10, PR negative	Invasive Breast Carcinoma	Carboplatin, Gemcitabine, Pembrolizumab