FDA Grants Enzalutamide Priority Review for Nonmetastatic CRPC

March 19, 2018 – The FDA has granted a priority review to a supplemental new drug application (sNDA) for enzalutamide for the treatment of men with nonmetastatic castration-resistant prostate cancer (CRPC), according to Pfizer and Astellas, the companies developing the antiandrogen agent. The sNDA is based on data from the phase III PROSPER trial in which the combination of enzalutamide and androgen deprivation therapy (ADT) reduced the risk of metastases … (leggi tutto)