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 [...]
Many of us in the United States with advanced prostate cancer who have failed Zytiga are looking to enter the Early Access MDV-3100 Clinical Trial. However, you need to be aware that there are some requirements you will need to meet prior to starting MDV-3100. You will need to wait 30 days after stopping Zytiga [...]
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 [...]