Shots:

• The approval is based on P-III Asian PREVAIL study assessing Xtandi (160mg/day) vs PBO + GnRH therapy or after bilateral orchiectomy in patients with progressive metastatic mCRPC who had disease progression despite ADT and a single dose PK study in 200 Chinese patients
• The P-III Asian PREVAIL study results: reduction in risk of PSA progression; median time to PSA progression (8.31 vs 2.86mos.); reduction in radiographic disease progression; improvement in OS; 67% reduction in the risk of death
• Xtandi is a nonsteroidal antiandrogen medication- indicated for use in conjunction with castration in the treatment of metastatic castration-resistant prostate cancer and nonmetastatic castration-resistant prostate cancer

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