Regulatory approval

Published by the Health Service Executive. Approved

The Republic of Ireland's Health Service Executive (HSE) has approved olaparib (tablet) for reimbursement as a monotherapy treatment option for the treatment of adult patients with metastatic castration-resistant prostate cancer whose tumors harbor 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:

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

Reimbursement

CDS

Citation

Olaparib (Tablet) Monotherapy, 2025, version number 5b, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6397/588_V5b_olaparib_tablet_monotherapy.pdf

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	BRCA1 oncogenic variants	Prostate Adenocarcinoma	Olaparib
HSE (1)	BRCA1 pathogenic variants	Prostate Adenocarcinoma	Olaparib
HSE (1)	BRCA2 oncogenic variants	Prostate Adenocarcinoma	Olaparib
HSE (1)	BRCA2 pathogenic variants	Prostate Adenocarcinoma	Olaparib

Contributions

Date	Contributor	Description
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2023-03-01	Health Service Executive	Indication approved for reimbursement.