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.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
HC (1)	BRCA1 oncogenic variants	Prostate Adenocarcinoma	Olaparib
HC (1)	BRCA1 pathogenic variants	Prostate Adenocarcinoma	Olaparib
HC (1)	BRCA2 oncogenic variants	Prostate Adenocarcinoma	Olaparib
HC (1)	BRCA2 pathogenic variants	Prostate Adenocarcinoma	Olaparib
HC (1)	ATM pathogenic variants	Prostate Adenocarcinoma	Olaparib
HC (1)	ATM oncogenic variants	Prostate Adenocarcinoma	Olaparib