There was a recent interview in the Pharma Strategy Blog with Dr. Bertrand Tombal , an academic urologist in Belgium. Dr. Tomal discussed several of the new advances in the treatment od advanced prostate cancer with an emphasis on the potential future of Enzalutamide (Xtandi). Like bicalutamide (Casodex), Xtandi works by blocking (inhibiting) testosterone from [...]
I have said many times that one of the more important issues facing our use of Provenge is when to start it and how to sequence this treatment with the other newly approved agents that have recently become available for men with advanced prostate cancer. There is occasional conversation that Provenge is already antiquated due [...]
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 [...]
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 [...]
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 [...]
