Early Access Program (EAP)

The Well Reviewed Guide to Advanced Prostate Cancer (A Survivor Perspective) Has Been Updated and is Now Available for a free Download

Somehow I have been negligent and not let people know that I have written and posted a major update of my “Guide to Advanced Prostate Cancer.” As in the past, it is available as a free download from the Malecare web site. Helping me to update the book was prostate cancer survivor Craig Pynn and my own caretaker, Wendy Lebowitz. Anyone reading the first edition will be surprised when you see how many changes and updates this edition has included. It now has a very extensive conversation about living in the world as a cancer survivor as well as more [...]

Results of the Earl Access Trial of Enzalutamide Leading to the FDA Approval

Malecare was actively involved, along with its partners, in setting up the early access trial for enzalutamide (Xtandi).  The trial was conducted after the final Phase 3 AFFIRM trial that was eventually used to obtain FDA approval had been stopped, but before the FDA and received the final submission of the data.  Given the significant positive results of the trial we felt that the drug needed to become available to those in need even though the FDA had not yet approved the treatment. We accomplished this task by creating an Open-Label Single-Arm study to designed to monitor the drug’s safety [...]

A Roundup of the Amazing Success of the Early Access Program – Bring Treatments to Men in Need Prior to the FDA Approval

Most people don't know of the great work that has been carried out by group of determined advocates on behalf of men with advanced prostate cancer. These hard working advocates, who reach out across different advocacy groups (Malecare, PCRI , PHEN, PAACT and USTOO) have formed a committee they call the The Early/Expanded Access Committee (EAP). The EAP meet with pharmaceutical companies on a regular basis to encourage them to make their promising drugs and treatments available to individuals before they have formally received FDA approval. They do this by the way of a vehicle they call the Early Access [...]

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