The American Society of Clinical Oncologists (ASCO) has started their annual conference in Chicago. I am anticipating a number of interesting and important abstracts that will be directly relevant to those of us with advanced prostate cancer. Among the first release of information comes an announcement from Medivation Inc. and Astellas Pharma Inc. who have [...]
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 [...]
Today, May 16, 2012, Dendreon, the makers of Provenge, disclosed a new analysis of data of its pivotal 512-patient study of men with castrate resistant prostate cancer who received sipuleucel-T (Provenge). The new analysis separated the men in the study into four quartiles based on their prostate-specific antigen (PSA) scores. The initial design of the [...]
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 [...]
Understanding and deciding on appropriate treatments for men with advanced prostate cancer can be confusing. All the treatments come with side effects and one never knows what the benefits might be for an individual. Even with good clinical trials, men with advanced prostate cancer still need to navigate a most unclear path. Provenge, ever since [...]
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 [...]
