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 advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube cancer, or primary peritoneal carcinoma who are in response (complete or partial) following first-line platinum-based chemotherapy.

This is written in the approval document as:

Maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA 1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube cancer, and primary peritoneal carcinoma who are in response (complete or partial) following completion of first-line 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

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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