Regulatory approval

Published by the Health Service Executive.

The Republic of Ireland's Health Service Executive (HSE) has approved olaparib (tablet) in combination with bevacizumab for reimbursement as a treatment option for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability.

This is written in the approval document as:

Olaparib in combination with bevacizumab for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability.

Citation

Olaparib (Tablet) and Bevacizumab Therapy, 2023, version number 1, NCCP National SACT Regimen, NCCP, viewed 18/01/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/gynaecology/746-olaparib-tablet-and-bevacizumab-therapy.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 Bevacizumab, Olaparib
HSE (1) BRCA1 pathogenic variants Ovarian Epithelial Tumor Bevacizumab, Olaparib
HSE (1) BRCA2 oncogenic variants Ovarian Epithelial Tumor Bevacizumab, Olaparib
HSE (1) BRCA2 pathogenic variants Ovarian Epithelial Tumor Bevacizumab, Olaparib
HSE (1) HRD Ovarian Epithelial Tumor Bevacizumab, Olaparib
HSE (1) BRCA1 oncogenic variants High-Grade Serous Fallopian Tube Cancer Bevacizumab, Olaparib
HSE (1) BRCA1 pathogenic variants High-Grade Serous Fallopian Tube Cancer Bevacizumab, Olaparib
HSE (1) BRCA2 oncogenic variants High-Grade Serous Fallopian Tube Cancer Bevacizumab, Olaparib
HSE (1) BRCA2 pathogenic variants High-Grade Serous Fallopian Tube Cancer Bevacizumab, Olaparib
HSE (1) HRD High-Grade Serous Fallopian Tube Cancer Bevacizumab, Olaparib
HSE (1) BRCA1 oncogenic variants Peritoneal Serous Carcinoma Bevacizumab, Olaparib
HSE (1) BRCA1 pathogenic variants Peritoneal Serous Carcinoma Bevacizumab, Olaparib
HSE (1) BRCA2 pathogenic variants Peritoneal Serous Carcinoma Bevacizumab, Olaparib
HSE (1) HRD Peritoneal Serous Carcinoma Bevacizumab, Olaparib