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 maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

This is written in the approval document as:

Maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer who are in response (complete response or partial) to platinum-based chemotherapy

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.

Organization(s) Biomarker(s) Cancer type Therapy(ies)
HSE (1) BRCA1 oncogenic variants Ovarian Epithelial Tumor Olaparib
HSE (1) BRCA1 pathogenic variants Ovarian Epithelial Tumor Olaparib
HSE (1) BRCA2 oncogenic variants Ovarian Epithelial Tumor Olaparib
HSE (1) BRCA2 pathogenic variants Ovarian Epithelial Tumor Olaparib
HSE (1) BRCA1 oncogenic variants High-Grade Serous Fallopian Tube Cancer Olaparib
HSE (1) BRCA1 pathogenic variants High-Grade Serous Fallopian Tube Cancer Olaparib
HSE (1) BRCA2 oncogenic variants High-Grade Serous Fallopian Tube Cancer Olaparib
HSE (1) BRCA2 pathogenic variants High-Grade Serous Fallopian Tube Cancer Olaparib
HSE (1) BRCA1 oncogenic variants Peritoneal Serous Carcinoma Olaparib
HSE (1) BRCA1 pathogenic variants Peritoneal Serous Carcinoma Olaparib
HSE (1) BRCA2 oncogenic variants Peritoneal Serous Carcinoma Olaparib
HSE (1) BRCA2 pathogenic variants Peritoneal Serous Carcinoma Olaparib