Talzenna (talazoparib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	2
TALZENNA is indicated in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).	23

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
HC (1)	BRCA1 oncogenic variants	Prostate Adenocarcinoma	Enzalutamide, Talazoparib
HC (1)	BRCA1 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Talazoparib
HC (1)	BRCA2 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Talazoparib
HC (1)	BRCA1 pathogenic variants	Prostate Adenocarcinoma	Enzalutamide, Talazoparib
HC (1)	BRCA2 oncogenic variants	Prostate Adenocarcinoma	Enzalutamide, Talazoparib
HC (1)	BRCA2 pathogenic variants	Prostate Adenocarcinoma	Enzalutamide, Talazoparib
HC (1)	ATM pathogenic variants	Prostate Adenocarcinoma	Enzalutamide, Talazoparib
HC (1)	ATM oncogenic variants	Prostate Adenocarcinoma	Enzalutamide, Talazoparib
HC (1)	ATR oncogenic variants	Prostate Adenocarcinoma	Enzalutamide, Talazoparib
HC (1)	CDK12 oncogenic variants	Prostate Adenocarcinoma	Enzalutamide, Talazoparib
HC (1)	ATR pathogenic variants	Prostate Adenocarcinoma	Enzalutamide, Talazoparib
HC (1)	FANCA oncogenic variants	Prostate Adenocarcinoma	Enzalutamide, Talazoparib
HC (1)	CHEK2 pathogenic variants	Prostate Adenocarcinoma	Enzalutamide, Talazoparib
HC (1)	CHEK2 oncogenic variants	Prostate Adenocarcinoma	Enzalutamide, Talazoparib
HC (1)	FANCA pathogenic variants	Prostate Adenocarcinoma	Enzalutamide, Talazoparib
HC (1)	MLH1 oncogenic variants	Prostate Adenocarcinoma	Enzalutamide, Talazoparib
HC (1)	PALB2 pathogenic variants	Prostate Adenocarcinoma	Enzalutamide, Talazoparib
HC (1)	PALB2 oncogenic variants	Prostate Adenocarcinoma	Enzalutamide, Talazoparib
HC (1)	MLH1 pathogenic variants	Prostate Adenocarcinoma	Enzalutamide, Talazoparib
HC (1)	MRE11 oncogenic variants	Prostate Adenocarcinoma	Enzalutamide, Talazoparib
HC (1)	RAD51C pathogenic variants	Prostate Adenocarcinoma	Enzalutamide, Talazoparib
HC (1)	RAD51C oncogenic variants	Prostate Adenocarcinoma	Enzalutamide, Talazoparib
HC (1)	MRE11 pathogenic variants	Prostate Adenocarcinoma	Enzalutamide, Talazoparib
HC (1)	NBN oncogenic variants	Prostate Adenocarcinoma	Enzalutamide, Talazoparib
HC (1)	NBN pathogenic variants	Prostate Adenocarcinoma	Enzalutamide, Talazoparib