Regulatory approval

Published by the Health Service Executive. Approved

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.

This is written in the approval document.

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

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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