Medivation, the pharmaceutical company that owns Xtandi (formerly known as MDV-3100), the new androgen receptor antagonist to treat castrate resistant advanced prostate cancer has a number of active clinical trials, despite the fact that it has already been approved for use. The current FDA approval is specific; it has been approved for men who are [...]
We all know that abiraterone acetate (Zytiga) plus prednisone provides a survival advantage for men with castrate resistant advanced prostate cancer (mCRPC) who have had prior treatment with a taxane based chemotherapy. New information has shown that abiraterone acetate offers a somewhat longer overall survival benefit than the data originally presented when the trial halted [...]
The summer is coming to a close and I am back, ready to again take on the world. I had the fantastic opportunity of spending almost two weeks in Alaska, a land that is so different from the lower 48. I have to say that I have a new found respect for those individuals who [...]
The Early/Expanded Access Committee has informed me that four additional sites have been added to the trial so there are now 23 States that have an expanded access trial of MDV3100 available to men with advanced prostate cancer. The trial is designed to monitor the safety of the drug in men with progressive castration-resistant advanced [...]
My very dear friend and advocate supreme, Jan Manarite, from PCRI has sent me an update on MDV3100 (enzalutamide). As usual her information is important, so I thought I would pass it on today. • She points out that once the FDA approves MDV3100 (I am going to work on the assumption that it will [...]
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 [...]
