Regulatory approval

Published by the European Medicines Agency. Approved

Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

This is written in the approval document.

Citation

AstraZeneca AB. Lynparza (olaparib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf. Revised August 2024. Accessed August 25, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	BRCA1 oncogenic variants	Ovarian Epithelial Tumor	Olaparib
EMA (1)	BRCA1 pathogenic variants	Ovarian Epithelial Tumor	Olaparib
EMA (1)	BRCA2 oncogenic variants	Ovarian Epithelial Tumor	Olaparib
EMA (1)	BRCA2 pathogenic variants	Ovarian Epithelial Tumor	Olaparib
EMA (1)	BRCA1 oncogenic variants	High-Grade Serous Fallopian Tube Cancer	Olaparib
EMA (1)	BRCA1 pathogenic variants	High-Grade Serous Fallopian Tube Cancer	Olaparib
EMA (1)	BRCA2 oncogenic variants	High-Grade Serous Fallopian Tube Cancer	Olaparib
EMA (1)	BRCA2 pathogenic variants	High-Grade Serous Fallopian Tube Cancer	Olaparib
EMA (1)	BRCA1 oncogenic variants	Peritoneal Serous Carcinoma	Olaparib
EMA (1)	BRCA1 pathogenic variants	Peritoneal Serous Carcinoma	Olaparib
EMA (1)	BRCA2 oncogenic variants	Peritoneal Serous Carcinoma	Olaparib
EMA (1)	BRCA2 pathogenic variants	Peritoneal Serous Carcinoma	Olaparib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2019-06-12	European Medicines Agency	Indication received approval from the European Commission.