Recently, it was announced that there was a submission by Astellas and Medivation to the European Regulatory Agency for Enzalutamide (MDV-3100) for the treatment of men with advanced prostate cancer post-chemotherapy The basis of the submission was the pivotal phase 3 AFFIRM study. The Marketing Authorization Application (MAA) that was made to the European Medicines [...]
I have heard some occasional discussion that once (that is if) enzalutamide (MDV-3100) is approved by the FDA for the treatment of men with advanced prostate cancer, it will over shadow Provenge. On the contrary, I believe that the approval of enzalutamide will actually encourage additional use of Provenge resulting in the increasing use of [...]
The Early/Expanded Access Committee has announced the addition of a new site in Atlanta, Ga for the trial of MDV-3100. According to my sources, there will be even more sites added in the near future. The role of the trial is to provide expanded Access to MDV3100 and monitor its safety in men with progressive [...]
The American Society of Clinical Oncologists (ASCO) has started their annual conference in Chicago. I am anticipating a number of interesting and important abstracts that will be directly relevant to those of us with advanced prostate cancer. Among the first release of information comes an announcement from Medivation Inc. and Astellas Pharma Inc. who have [...]
I now have some additional information about the Early/Expanded Access Program for Enzalutamide (MDV-3100)for men with advanced prostate cancer. Jan Manarite, who is a member of the Early Access Committee has provided the following information: From the Early/Expanded Access Committee - Now available in 10 states (see list below in this post) with additional 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 [...]
