There was just a new site opened for the early/expanded access program for Alpharedin (Radium-235). The new site is at Stanford University, California. This makes a total of four sites, but most of them have not been adequately supported by the drug company, Bayer. Hopefully, this site will be better supported, but if it too [...]
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 [...]
Our Prostate Cancer community was happy when Bayer and Algeta announced an Early/Expanded Access Program for Alpharedin. However we notice that, as of today, there is only one clinical trial site that is currently open and taking any new patients. However, this site is limited to only 2 men per month and their waiting list [...]
Dr. Moyad has been the driving force behind getting the Early Access Program for drugs to treat advanced prostate cancer. Along with the Early Access Committee he has arranged for an early access (before the formal approval from the FDA) for both Zytiga and now MDV3100. (you can read about the programs including how to [...]
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 [...]
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 [...]
