FDA Grants Enzalutamide Priority Review for Metastatic Hormone-Sensitive Prostate Cancer

Aug 21, 2019 – The FDA has granted a priority review designation to a supplemental new drug application for enzalutamide for the treatment of men with metastatic hormone-sensitive prostate cancer (mHSPC), according to Astellas Pharma Inc. and Pfizer Inc., the codevelopers of the androgen receptor inhibitor. The designation, which will expedite the development and review of enzalutamide in this setting, is based on data from the phase III ARCHES and ENZAMET … (leggi tutto)