There has been a lot of news in the area of early access for great drugs to treat advanced prostate cancer prior to the FDA’s approval. I have informed you about the Early Access Program for MDV-3100 in men with castrate resistant prostate cancer previously treated with a Docetaxel based chemotherapy agent. The latest news [...]
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 [...]
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 [...]
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 [...]
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 [...]