Regulatory approval

Published by the Health Canada. Approved

TALZENNA (talazoparib) is indicated as a monotherapy for the treatment of adult patients with a deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated human epidermal growth factor receptor 2 (HER2)-negative locally advanced (not amenable to curative radiation or surgery) or metastatic breast cancer, who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting, unless patients were inappropriate for these treatments.

This is written in the approval document.

Citation

Pfizer Canada ULC. Talzenna (talazoparib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00083453.PDF. Revised February 2026. Accessed April 2026.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HC (1)	BRCA1 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Talazoparib
HC (1)	BRCA2 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Talazoparib