Lynparza (olaparib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

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.

Regulatory approvals

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

Indication	Statements
LYNPARZA (olaparib) is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients must have confirmation of a germline BRCA mutation before LYNPARZA treatment is initiated.	2
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.	2
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.	12
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.	12
LYNPARZA (olaparib) is indicated as monotherapy for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas whose disease has not progressed on a minimum of 16 weeks of first-line platinum-based chemotherapy. Germline BRCA mutation must be confirmed before LYNPARZA treatment is initiated.	2
LYNPARZA (olaparib) is indicated as monotherapy for the treatment of adult patients with deleterious or suspected deleterious germline and/or somatic BRCA or ATM mutated metastatic castrationresistant Prostate Cancer (mCRPC) who have progressed following prior treatment with a new hormonal agent. BRCA or ATM mutations must be confirmed before LYNPARZA treatment is initiated.	6
LYNPARZA is indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious germline and/or somatic BRCA mutated metastatic castration resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. BRCA mutation must be confirmed before LYNPARZA treatment is initiated.	8

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	BRCA1 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Olaparib
Sensitivity (+)	BRCA2 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Olaparib
Sensitivity (+)	BRCA1 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Olaparib
Sensitivity (+)	BRCA2 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Olaparib
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
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
Sensitivity (+)	BRCA1 pathogenic variants	Pancreatic Adenocarcinoma	Olaparib
Sensitivity (+)	BRCA2 pathogenic variants	Pancreatic Adenocarcinoma	Olaparib
Sensitivity (+)	BRCA1 oncogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	BRCA1 pathogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	BRCA2 oncogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	BRCA2 pathogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	ATM pathogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	ATM oncogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	BRCA1 oncogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Olaparib, Prednisolone
Sensitivity (+)	BRCA1 pathogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Olaparib, Prednisolone
Sensitivity (+)	BRCA2 oncogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Olaparib, Prednisolone
Sensitivity (+)	BRCA2 pathogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Olaparib, Prednisolone
Sensitivity (+)	BRCA1 oncogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Olaparib, Prednisone
Sensitivity (+)	BRCA1 pathogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Olaparib, Prednisone
Sensitivity (+)	BRCA2 oncogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Olaparib, Prednisone
Sensitivity (+)	BRCA2 pathogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Olaparib, Prednisone