FDA Grants Niraparib Breakthrough Designation for BRCA+ mCRPC

Oct 3, 2019 – The FDA has granted a breakthrough therapy designation to the PARP inhibitor niraparib for the treatment of patients with BRCA1/2–mutant metastatic castration-resistant prostate cancer (mCRPC) who have previously received taxane-based chemotherapy and an androgen receptor (AR) inhibitor. The decision is based on findings from the phase II GALAHAD study (NCT02854436), in which niraparib demonstrated a 41% objective response rate (ORR) in … (leggi tutto)