FDA Approval Sought for Apalutamide in Metastatic Castration-Sensitive Prostate Cancer

April 29, 2019 – A supplemental new drug application (sNDA) has been submitted to the FDA for the approval of apalutamide for use as a treatment of patients with metastatic castration-sensitive prostate cancer, according to Janssen, the manufacturer of the next-generation androgen receptor inhibitor. The application is based on data from the phase III TITAN trial (NCT02489318), which showed that apalutamide plus androgen deprivation therapy (ADT) significantly improved … (leggi tutto)