Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BRCA2 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.