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Astellas : China Okays XTANDI For Treatment Of Adult Men With Metastatic CRPC

Astellas Pharma Inc. (ALPMY,ALPMY) said that the China National Medical Products Administration approved a new drug application for XTANDI or enzalutamide for the treatment of adult men with metastatic castration-resistant prostate cancer or CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy or ADT 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 ADT and a single-dose pharmacokinetic study in healthy Chinese volunteers.

The study, Asian PREVAIL, evaluated oral enzalutamide (160 mg/day) versus placebo plus gonadotropin-releasing hormone (GnRH) therapy or after bilateral orchiectomy.

The study, involving Asian patients including about 200 Chinese patients, showed consistent results with those in the global pivotal Phase 3 PREVAIL study in the same target population.

Prostate cancer is considered metastatic once the cancer has spread outside of the prostate gland to other parts of the body. Metastatic CRPC is fatal, with a median survival of approximately 3-4 years for men starting treatment with ADT.

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