Regulatory approval

Published by the Health Canada.

Health Canada approved olaparib as an add-on maintenance treatment to bevacizumab of adult patients with advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation and/or genomic instability.

This is written in the approval document as:

LYNPARZA (olaparib) is indicated as an add-on maintenance treatment to bevacizumab of adult patients with advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation and/or genomic instability. BRCA mutation status (germline or somatic) and/or genomic instability must be confirmed 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.

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 Bevacizumab, Olaparib
Sensitivity (+) BRCA1 pathogenic variants Ovarian Epithelial Tumor Bevacizumab, Olaparib
Sensitivity (+) BRCA2 oncogenic variants Ovarian Epithelial Tumor Bevacizumab, Olaparib
Sensitivity (+) BRCA2 pathogenic variants Ovarian Epithelial Tumor Bevacizumab, Olaparib
Sensitivity (+) BRCA1 oncogenic variants High-Grade Serous Fallopian Tube Cancer Bevacizumab, Olaparib
Sensitivity (+) BRCA1 pathogenic variants High-Grade Serous Fallopian Tube Cancer Bevacizumab, Olaparib
Sensitivity (+) BRCA2 oncogenic variants High-Grade Serous Fallopian Tube Cancer Bevacizumab, Olaparib
Sensitivity (+) BRCA2 pathogenic variants High-Grade Serous Fallopian Tube Cancer Bevacizumab, Olaparib
Sensitivity (+) BRCA1 oncogenic variants Peritoneal Serous Carcinoma Bevacizumab, Olaparib
Sensitivity (+) BRCA1 pathogenic variants Peritoneal Serous Carcinoma Bevacizumab, Olaparib
Sensitivity (+) BRCA2 oncogenic variants Peritoneal Serous Carcinoma Bevacizumab, Olaparib
Sensitivity (+) BRCA2 pathogenic variants Peritoneal Serous Carcinoma Bevacizumab, Olaparib