Olaparib (Tablet) Monotherapy. NCCP National SACT Regimen. HSE.

Regulatory approval published by the Health Service Executive.

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

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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	12
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	12
As monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.	4
As monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy. Lynparza's product information fromcites the OlympiA trial, where olaparib was compared against placebo for the treatment of patients with germline BRCA1/2 mutated and HER2-negative high risk early breast cancer.	2
As monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	BRCA1 oncogenic variants	Ovarian Epithelial Tumor	Olaparib
Sensitivity (+)	BRCA1 pathogenic variants	Ovarian Epithelial Tumor	Olaparib
Sensitivity (+)	BRCA2 oncogenic 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 (+)	BRCA1 pathogenic variants	High-Grade Serous Fallopian Tube Cancer	Olaparib
Sensitivity (+)	BRCA2 oncogenic 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 (+)	BRCA1 pathogenic variants	Peritoneal Serous Carcinoma	Olaparib
Sensitivity (+)	BRCA2 oncogenic variants	Peritoneal Serous Carcinoma	Olaparib
Sensitivity (+)	BRCA2 pathogenic variants	Peritoneal Serous Carcinoma	Olaparib
Sensitivity (+)	BRCA1 oncogenic variants	Ovarian Epithelial Tumor	Olaparib
Sensitivity (+)	BRCA1 pathogenic variants	Ovarian Epithelial Tumor	Olaparib
Sensitivity (+)	BRCA2 oncogenic 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 (+)	BRCA1 pathogenic variants	High-Grade Serous Fallopian Tube Cancer	Olaparib
Sensitivity (+)	BRCA2 oncogenic 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 (+)	BRCA1 pathogenic variants	Peritoneal Serous Carcinoma	Olaparib
Sensitivity (+)	BRCA2 oncogenic variants	Peritoneal Serous Carcinoma	Olaparib
Sensitivity (+)	BRCA2 pathogenic variants	Peritoneal Serous Carcinoma	Olaparib
Sensitivity (+)	BRCA1 oncogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	BRCA1 pathogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	BRCA2 oncogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	BRCA2 pathogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	BRCA1 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Olaparib
Sensitivity (+)	BRCA2 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Olaparib
Sensitivity (+)	BRCA1 pathogenic variants	Pancreatic Adenocarcinoma	Olaparib
Sensitivity (+)	BRCA2 pathogenic variants	Pancreatic Adenocarcinoma	Olaparib