Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to pembrolizumab in combination with chemotherapy for the neoadjuvant treatment, and then pembrolizumab continued as a single agent as adjuvant treatment after surgery, of patients with high-risk early-stage triple negative breast cancer (TNBC). This indication is based on KEYNOTE-522 (NCT03036488), a randomized (2:1), multicenter, double-blind, placebo-controlled trial where the chemotherapy regimen consisted of carboplatin, paclitaxel, doxorubicin, and cyclophosphamide.

This is written in the approval document as:

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.

Citation

Merck Sharp & Dohme Corp. Keytruda (pembrolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125514s174lbl.pdf. Revised April 2025. Accessed April 30, 2025.

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	ER negative, HER2-negative, PR negative	Invasive Breast Carcinoma	Carboplatin, Cyclophosphamide, Doxorubicin, Paclitaxel, Pembrolizumab