Medivation, (MDVN), Astellas Pharma to Proceed with EAP for Enzalutamide
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Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (Tokyo: 4503) announced that the U.S. Food and Drug Administration (FDA) agreed that Medivation and Astellas may proceed with an Expanded Access Program (EAP) for the investigational therapy enzalutamide (formerly MDV3100) under a treatment protocol in the U.S. 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 approximately 75 centers in the U.S. 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.
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 approximately 75 centers in the U.S. 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.
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