Regulatory approval

Published by the Health Canada.

Health Canada approved olaparib as monotherapy for the maintenance treatment of adult patients with advanced BRCA-mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to first-line platinum-based chemotherapy.

This is written in the approval document as:

LYNPARZA (olaparib) is indicated as monotherapy for the maintenance treatment of adult patients with advanced BRCA-mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to first-line platinum-based chemotherapy. Patients must have confirmation of BRCA mutation (identified by either germline or tumour testing) before LYNPARZA treatment is initiated.

Citation

AstraZeneca Canada Inc. Lynparza (olaparib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00080379.PDF. Published April 2025. Accessed June 2025.

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Therapeutic response

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

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) BRCA1 oncogenic variants Ovarian Epithelial Tumor Olaparib
Sensitivity (+) BRCA1 pathogenic variants Ovarian Epithelial Tumor Olaparib
Sensitivity (+) BRCA2 oncogenic variants Ovarian Epithelial Tumor Olaparib
Sensitivity (+) BRCA2 pathogenic variants Ovarian Epithelial Tumor Olaparib
Sensitivity (+) BRCA1 oncogenic variants High-Grade Serous Fallopian Tube Cancer Olaparib
Sensitivity (+) BRCA1 pathogenic variants High-Grade Serous Fallopian Tube Cancer Olaparib
Sensitivity (+) BRCA2 oncogenic variants High-Grade Serous Fallopian Tube Cancer Olaparib
Sensitivity (+) BRCA2 pathogenic variants High-Grade Serous Fallopian Tube Cancer Olaparib
Sensitivity (+) BRCA1 oncogenic variants Peritoneal Serous Carcinoma Olaparib
Sensitivity (+) BRCA1 pathogenic variants Peritoneal Serous Carcinoma Olaparib
Sensitivity (+) BRCA2 oncogenic variants Peritoneal Serous Carcinoma Olaparib
Sensitivity (+) BRCA2 pathogenic variants Peritoneal Serous Carcinoma Olaparib