FDA Grants Olaparib Priority Review for Frontline Maintenance in Ovarian Cancer

November 12, 2018 – The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for olaparib tablets for use as a maintenance therapy in patients with newly-diagnosed, BRCA-positive advanced ovarian cancer who achieved a complete or partial response to standard frontline platinum-based chemotherapy. The sNDA is based on data from the phase III SOLO-1 trial, in which the PARP inhibitor olaparib significantly improved .. (leggi tutto)