Regulatory approval

Published by the Health Service Executive.

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.

Citation

Olaparib (Tablet) Monotherapy, 2025, version number 5b, NCCP National SACT Regimen, NCCP, viewed 01/10/2025, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/oral-anti-cancer-medicines/588-olaparib-tablet-monotherapy.pdf

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 (+) BRCA2 oncogenic variants Prostate Adenocarcinoma Olaparib
Sensitivity (+) BRCA1 pathogenic variants Prostate Adenocarcinoma Olaparib
Sensitivity (+) BRCA2 pathogenic variants Prostate Adenocarcinoma Olaparib