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, 2023, version number 3, NCCP National SACT Regimen, NCCP, viewed 18/01/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/gynaecology/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 Ovarian Epithelial Tumor Olaparib
Sensitivity (+) BRCA2 oncogenic variants Ovarian Epithelial Tumor Olaparib
Sensitivity (+) BRCA1 pathogenic variants Ovarian Epithelial Tumor Olaparib
Sensitivity (+) BRCA2 pathogenic variants Ovarian Epithelial Tumor Olaparib
Sensitivity (+) BRCA1 oncogenic variants High-Grade Serous Fallopian Tube Cancer Olaparib
Sensitivity (+) BRCA2 oncogenic variants High-Grade Serous Fallopian Tube Cancer Olaparib
Sensitivity (+) BRCA1 pathogenic variants High-Grade Serous Fallopian Tube Cancer Olaparib
Sensitivity (+) BRCA2 pathogenic variants High-Grade Serous Fallopian Tube Cancer Olaparib
Sensitivity (+) BRCA1 oncogenic variants Peritoneal Serous Carcinoma Olaparib
Sensitivity (+) BRCA2 oncogenic variants Peritoneal Serous Carcinoma Olaparib
Sensitivity (+) BRCA1 pathogenic variants Peritoneal Serous Carcinoma Olaparib
Sensitivity (+) BRCA2 pathogenic variants Peritoneal Serous Carcinoma Olaparib