Expanded Access Program for enzalutamide agreed with US FDA

The US Food and Drug Administration agreed that Medivation (Nasdaq: MDVN) and Japanese drug major Astellas Pharma (TYO: 4503) may proceed with an Expanded Access Program (EAP) for their investigational prostate cancer therapy enzalutamide (formerly MDV3100) under a treatment protocol in the US while marketing approval is being sought from the FDA.

The EAP is now enrolling eligible men with metastatic castration-resistant prostate cancer previously treated with docetaxel chemotherapy. Medivation and Astellas intend for investigators at around 75 centers in the USA to participate in the EAP study to provide expanded access to enzalutamide until the drug becomes commercially available, should it receive approval. This study is sponsored by Medivation and Astellas Pharma Global Development.

"We are truly grateful that Astellas and Medivation worked closely with our volunteer committee from around the USA, to turn the vision of an Early Access Program into a reality. Our mission at the Early Access Program for Prostate Cancer patients (EAPPCa) is to assist in bringing potential new medications to the most advanced cancer patients after a successful Phase III trial and before a final FDA decision," Mark Moyad, of the University of Michigan Medical Center, Department of Urology, and Tom Kirk, president and chief executive of Us TOO International, said in a joint statement.