Regulatory approvals
ind:hc:talzenna:1
Regulatory approval
Published by the Health Canada .
Approved
Health Canada approved talazoparib 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 as:
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).
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
1 organization
Cancer types
1 cancer type
Organizations
Biomarkers
Cancer types
Therapies
HC (1)
BRCA1 oncogenic variants
Prostate Adenocarcinoma
Enzalutamide ,
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
Contributions
Date
Contributor
Description
2024-10-30
Van Allen lab
Initial access of FDA approvals