FDA Grants Maintenance Olaparib Priority Review for Ovarian Cancer

March 28, 2017 – The FDA has granted a priority review to a new drug application (NDA) for olaparib as a maintenance therapy in relapsed patients with platinum-sensitive ovarian cancer, according to AstraZeneca, the manufacturer of the PARP inhibitor. The NDA is based on data from the phase III SOLO2 trial, in which maintenance olaparib showed a 70% reduction in the risk of progression or death compared with placebo for patients with platinum-sensitive, relapsed, BRCA-mutant … (leggi tutto)