FDA Grants Rucaparib Breakthrough Designation for mCRPC

October 2, 2018 – The FDA has granted the PARP inhibitor rucaparib a breakthrough therapy designation for single-agent use in adult patients with BRCA1/2-positive metastatic castration-resistant prostate cancer (mCRPC) following at least 1 androgen receptor–directed therapy and taxane-based chemotherapy. The designation, which will expedite the development and review of rucaparib in this setting, is based on initial data from the ongoing TRITON2 phase II study in … (leggi tutto)