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

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	Bevacizumab, Olaparib
Sensitivity (+)	BRCA2 oncogenic variants	Ovarian Epithelial Tumor	Bevacizumab, Olaparib
Sensitivity (+)	BRCA1 pathogenic variants	Ovarian Epithelial Tumor	Bevacizumab, Olaparib
Sensitivity (+)	BRCA2 pathogenic variants	Ovarian Epithelial Tumor	Bevacizumab, Olaparib
Sensitivity (+)	BRCA1 oncogenic variants	High-Grade Serous Fallopian Tube Cancer	Bevacizumab, Olaparib
Sensitivity (+)	BRCA2 oncogenic variants	High-Grade Serous Fallopian Tube Cancer	Bevacizumab, Olaparib
Sensitivity (+)	BRCA1 pathogenic variants	High-Grade Serous Fallopian Tube Cancer	Bevacizumab, Olaparib
Sensitivity (+)	BRCA2 pathogenic variants	High-Grade Serous Fallopian Tube Cancer	Bevacizumab, Olaparib
Sensitivity (+)	BRCA1 oncogenic variants	Peritoneal Serous Carcinoma	Bevacizumab, Olaparib
Sensitivity (+)	BRCA2 pathogenic variants	Peritoneal Serous Carcinoma	Bevacizumab, Olaparib
Sensitivity (+)	BRCA1 pathogenic variants	Peritoneal Serous Carcinoma	Bevacizumab, Olaparib
Sensitivity (+)	HRD	Ovarian Epithelial Tumor	Bevacizumab, Olaparib
Sensitivity (+)	HRD	High-Grade Serous Fallopian Tube Cancer	Bevacizumab, Olaparib
Sensitivity (+)	HRD	Peritoneal Serous Carcinoma	Bevacizumab, Olaparib