Phase III trial of MDV 3100 (Medivation/Astellas) shows significant benefits for patients with advanced Prostate Cancer

An analysis of a Phase III trial of men with advanced Prostate Cancer treated using MDV 3100, from Medivation and Astellas, shows the AFFIRM trial has met its interim efficacy stopping criteria by demonstrating a statistically significant improvement in survival. Those on the drug outlived those on placebo by an average of 4.8 months, and the trial has been stopped early so those on placebo can start taking MDV 3100. Medivation and Astellas now plan to hold a pre-NDA meeting with the US FDA in early 2012. If approved, MDV 3100 will compete with Zytiga.