Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that BRCA1 pathogenic variants status confers therapeutic sensitivity to Olaparib in patients with High-Grade Serous Fallopian Tube Cancer.

The European Medicines Agency (EMA) has authorized olaparib as a 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 statement is based on a regulatory approval from the European Medicines Agency:

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.

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.

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.