Medivation and Astellas Announce Initiation of Expanded Access Program for Enzalutamide (MDV3100) in the United States for men with metastatic prostate cancer previously treated with chemotherapy.
Medivation, Inc. and Astellas Pharma Inc. today announced that they have come to an agreement with the U.S. Food and Drug Administration (FDA) which will allow them to proceed with an Expanded Access Program (EAP) for the investigational therapy enzalutamide (formerly MDV3100) under a treatment protocol in the U.S. while they continue to seek general approval from the FDA.
They are now enrolling eligible men with metastatic castration-resistant prostate cancer previously treated with docetaxel chemotherapy. According to Medivation and Astellas they intend for investigators at approximately 75 centers in the U.S. to participate in the early access program study to provide expanded access to enzalutamide until the drug becomes commercially available, should it receive approval.
Medivation and Astellas submitted the New Drug Application for enzalutamide to the FDA on May 21, 2012. Our hope is that they will receive approval in this calendar year.
More information about the enzalutamide EAP study, including participating centers and eligibility criteria, is available by calling 855-412-7865 or by visiting http://www.clinicaltrials.gov .
Enzalutamide (MDV3100) is an oral, once-daily investigational agent that is an androgen receptor signaling inhibitor. Enzalutamide inhibits androgen receptor signaling in three distinct ways, by inhibiting:
1) testosterone binding to androgen receptors.
2) nuclear translocation of androgen receptors.
3) DNA binding and activation by androgen receptors.
In the Phase 3 AFFIRM trial, enzalutamide was well tolerated.
Common side effects observed more frequently in enzalutamide as compared with placebo-treated patients included fatigue, diarrhea and hot flush. Seizure was reported in < 1% of enzalutamide-treated patients. Serious adverse events, adverse events causing patients to stop treatment, and adverse events causing death all were lower in the enzalutamide group than in the placebo group.Joel T. Nowak, M.A., M.S.W.