Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to olaparib in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. 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 in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. 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.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	BRCA1 oncogenic variants	Ovarian Epithelial Tumor	Bevacizumab, Olaparib
FDA (2)	BRCA1 pathogenic variants	Ovarian Epithelial Tumor	Bevacizumab, Olaparib
FDA (2)	BRCA2 oncogenic variants	Ovarian Epithelial Tumor	Bevacizumab, Olaparib
FDA (2)	BRCA2 pathogenic variants	Ovarian Epithelial Tumor	Bevacizumab, Olaparib
FDA (2)	HRD	Ovarian Epithelial Tumor	Bevacizumab, Olaparib
FDA (2)	BRCA1 oncogenic variants	High-Grade Serous Fallopian Tube Cancer	Bevacizumab, Olaparib
FDA (2)	BRCA1 pathogenic variants	High-Grade Serous Fallopian Tube Cancer	Bevacizumab, Olaparib
FDA (2)	BRCA2 oncogenic variants	High-Grade Serous Fallopian Tube Cancer	Bevacizumab, Olaparib
FDA (2)	BRCA2 pathogenic variants	High-Grade Serous Fallopian Tube Cancer	Bevacizumab, Olaparib
FDA (2)	HRD	High-Grade Serous Fallopian Tube Cancer	Bevacizumab, Olaparib
FDA (2)	BRCA1 oncogenic variants	Peritoneal Serous Carcinoma	Bevacizumab, Olaparib
FDA (2)	BRCA1 pathogenic variants	Peritoneal Serous Carcinoma	Bevacizumab, Olaparib
FDA (2)	BRCA2 oncogenic variants	Peritoneal Serous Carcinoma	Bevacizumab, Olaparib
FDA (2)	BRCA2 pathogenic variants	Peritoneal Serous Carcinoma	Bevacizumab, Olaparib
FDA (2)	HRD	Peritoneal Serous Carcinoma	Bevacizumab, Olaparib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2020-05-08	Food and Drug Administration	Indication received traditional approval.