Posted by Michael Wonder on 27 Nov 2019
Astellas announces the approval of Xtandi (enzalutamide) by the China National Medical Products Administration approval based on Asian PREVAIL study of men with metastatic castration-resistant prostate cancer
26 November 2019 - Astellas Pharma today announced that the China National Medical Products Administration approved a new drug application for Xtandi (enzalutamide) on November 18 for the treatment of adult men with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.
The approval was based on the results of an Asian multinational Phase 3, randomized, double-blind, placebo controlled efficacy and safety study of enzalutamide in asymptomatic or mildly symptomatic patients with progressive metastatic prostate cancer who had disease progression despite androgen deprivation therapy and a single-dose pharmacokinetic study in healthy Chinese volunteers (Protocol 9785-CL-0013).
