Astellas’ Xtandi (enzalutamide) Receives NMPA’s Approval for Metastatic Castration-Resistant Prostate Cancer in Men

Astellas’ Xospata (gilteritinib) Receives FDA ‘s Approval for 1L R/R Acute Myeloid Leukemia (AML) in Adults

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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