Regulatory approval

Published by the Health Canada. Approved

LYNPARZA (olaparib) is indicated as monotherapy for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2- negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have progressed on or be considered inappropriate for endocrine therapy. Germline BRCA mutation must be confirmed before LYNPARZA treatment is initiated.

This is written in the approval document.

Citation

AstraZeneca Canada Inc. Lynparza (olaparib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00080849.PDF. Published June 2025. 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 Olaparib
HC (1) BRCA2 pathogenic variants, HER2-negative Invasive Breast Carcinoma Olaparib