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/2021/125514s089s114lbl.pdf. Revised July 2021. Accessed October 6, 2026.

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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 high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. 1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (1) ER negative, HER2-negative, PR negative Invasive Breast Carcinoma Carboplatin, Cyclophosphamide, Doxorubicin, Paclitaxel, Pembrolizumab