NEW YORK CITY (dpa-AFX) - Pfizer Inc. (PFE) and Astellas Pharma Inc. announced that the Phase 3 PROSPER trial evaluating XTANDI (enzalutamide) plus androgen deprivation therapy versus androgen deprivation therapy alone in patients with non-metastatic Castration-Resistant Prostate Cancer met its primary endpoint of improved metastasis-free survival. The companies said the preliminary safety analysis of the PROSPER trial appears consistent with the safety profile of XTANDI in previous clinical trials. Based on the results, the companies intend to discuss the data with global health authorities to potentially support expanding the label for XTANDI to cover all patients with Castration-Resistant Prostate Cancer.
XTANDI is currently approved for the treatment of metastatic Castration-Resistant Prostate Cancer based on clinical data from previous studies that showed a statistically significant overall survival benefit for XTANDI versus placebo in the metastatic CRPC setting.
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