Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to olaparib for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Olaparib's product label specifies to select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

This is written in the approval document as:

Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

Citation

AstraZeneca Pharmaceuticals, LP. Lynparza (olaparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s028lbl.pdf. Revised November 2023. Accessed October 30, 2024.

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 (+)	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