CHMP Makes A Positive Recommendation on the Use of Xtandi

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has granted approval of Xtandi in the treatment of men with castrate resistant prostate cancer that has progressed after the use of chemotherapy. It has already been approved for use in the United States. Xtandi (aka Enzalutamide and MDV3100) is a strong androgen [...]

New Sites Added for the Early/Expanded Access Program for Enzalutamide (MDV3100)

It has just been announced that there are now two new additional sites added to the Early/Expanded Access Program for Enzalutamide (MDV3100). The program is technically a clinical trial designed to monitor MDV-3100’s safety in men with progressive castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy. This means that there are now a total of [...]

Breaking News- MDV-3100 Starts an Expanded Access Program in the United States

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 [...]