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 [...]
Medivation and Astellas Announce Initiation of Expanded Access Program for Enzalutamide (MDV3100) in the United States for men with metastatic prostate cancer previously treated with chemotherapy. Medivation, Inc. and Astellas Pharma Inc. today announced that they have come to an agreement with the U.S. Food and Drug Administration (FDA) which will allow them to proceed [...]
The recent AUA meetings in Atlanta had a number of interesting abstracts presented that concern men with advanced prostate cancer. Some of the more interesting abstracts were look back analysis of sipuleucel-T (Provenge) done by consultants for Dendreon, the company who manufactures Provenge. They took the data from the al three of the phase III [...]
Tokai, a Cambridge, MA based Pharmaceutical company, just presented a promising set of Phase I data pointing to the early efficacy of its "triple whammy" pill for castration-resistant prostate cancer, TOK-001 or galeterone. In their phase 1 trial the PSA levels in about half of the 49 men in the dose-ranging study declined 30% or [...]
I have had a number of recent conversations with men with advanced prostate cancer who have been taking Abiraterone Acetate (Zytiga). The question that comes up in regular conversation is about knowing when Zytiga has stopped working or when Zytiga should be discontinued. All the real guidance we have to answer this question comes from [...]
Radium-223 Chloride (Alpharadin) is now available for the treatment of men with advanced prostate cancer who have symptomatic bone metastases (painful) and who are also castration-resistant (hormone-refractory). This is an expanded access program that will allow the use of Alpharadin prior to the formal FDA approval of the treatment. From the Clinical Trials Web Page [...]
GTx Inc. announced that FDA regulators will allow it to restart the clinical trials of its investigational prostate cancer drug Capesaris for men with castrate resistant advanced prostate cancer. They anticipate that the trials of Capesaris will begin during the third quarter of 2012. The trial is designed to evaluate Capesaris as a secondary treatment [...]
For a reason that I can not figure out there are a small but still significant portion of medical studies that automatically exclude gays from participating without an apparent scientific reason. These studies usually have requirements that the subject be in a “reciprocal relationship with a person of the opposite sex." Sometimes the exclusion of [...]
According to recent trials led by The Institute of Cancer Research (ICR) (UK) and The Royal Marsden (UK) combining Zytiga (abiraterone acetate) with the yet FDA unapproved investigational drug MDV3100 could increase the number of men, with advanced prostate cancer, who respond to treatment as well as the length of time they benefit. A new [...]
I am interrupting the reviews of the AACR meeting to inform you of a very important piece of news. Men with advanced prostate cancer which is castrate resistant and who have 2 blaistic bone metastases may now have access to Alpharadin even though the FDA has not yet approved it in the United States! It [...]
