Positive results for Phase III study of enzalutamide (Medivation) for Prostate Cancer treatment

Results from a Phase III clinical trial show that enzalutamide (formerly MDV 3100), from Medivation, prolongs lives of patients with Prostate Cancer. Patients in the AFFIRM trial who had stopped responding to chemotherapy evaluated 27 factors, including pain and energy levels and ability to work while taking MDV 3100. Results showed that around 43% of men taking the drug experienced an improved quality of life compared to 18% of those on placebo. MDV 3100 was well tolerated and produced no serious adverse effects. Patients taking MDV 3100 also lived an average of 18.4 months vs. 13.6 months for those taking placebo. Results were presented at the ASCO meeting. Medivation submitted a New Drug Application (NDA) to the FDA in May 2012 and is preparing to submit the drug for approval in Europe and Japan.