Therapy Areas: Oncology
Lynparza Approved in the EU for Use as First-Line Maintenance Therapy in Patients With BRCA-Mutated Advanced Ovarian Cancer
21 June 2019 - - The European Commission has approved Lynparza as monotherapy for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (BRCAm) (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, British-Swedish drugmaker AstraZeneca and US-based Merck (NYSE: MRK) said.
The EU approval was based on data from the randomized, double-blinded Phase 3 SOLO-1 trial which evaluated LYNPARZA as maintenance monotherapy compared with placebo in patients with BRCAm advanced ovarian cancer following first-line platinum-based chemotherapy.
The trial results showed that Lynparza reduced the risk of disease progression or death by 70% versus placebo following response to platinum-based chemotherapy (HR 0.30 [95% CI 0.23-0.41], p
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