Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized olaparib as a monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.

This is written in the approval document as:

Lynparza is indicated as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.

Citation

AstraZeneca AB. Lynparza (olaparib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf. Revised August 2024. Accessed August 25, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

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