FDA Grants Priority Review to Niraparib for Late-Stage Ovarian Cancer

June 24, 2019 – The FDA has granted a priority review designation to a supplemental biologics license application for niraparib for the treatment of patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with ≥3 or more prior chemotherapy regimens, and who have either a BRCA mutation or have homologous recombination deficiency (HRD) and progressed >6 months after their last platinum-based chemotherapy. The designation is based on … (leggi tutto)