Regulatory approval

Published by the Health Canada.

Health Canada approved olaparib 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.

This is written in the approval document as:

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.

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	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