Therapy Areas: Devices
AstraZeneca and US Merck's Lynparza Approved in Japan as First-Line Maintenance Therapy in Patients with BRCA-Mutated Advanced Ovarian Cancer
25 June 2019 - - Japan's Pharmaceuticals and Medical Devices Agency has approved Lynparza as a maintenance treatment after first-line chemotherapy in patients with BRCA-mutated (BRCAm) ovarian cancer, British-Swedish drugmaker AstraZeneca and US-based Merck (NYSE: MRK) said.
The approval in Japan 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.
Results from the SOLO-1 trial 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