Regulatory approval

Published by the Health Canada.

Health Canada approved olaparib 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.

This is written in the approval document as:

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.

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	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