Regulatory approval

Published by the Health Canada. Approved

KEYTRUDA (pembrolizumab), in combination with chemotherapy, is indicated for the treatment of adult patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC), who have not received prior chemotherapy for metastatic disease and whose tumours express PD-L1 (Combined Positive Score [CPS] >= 10) as determined by a validated test.

This is written in the approval document.

Citation

Merck Canada Inc. Keytruda (pembrolizumab) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00083378.PDF. Published January 2026. Accessed April 2026.

Therapeutic response

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

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

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals