early access

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 [...]

By Malecare|2020-02-04T10:11:36-05:00June 25th, 2014|2nd line hormone therapy, Advanced Prostate Cancer, Cabazitaxel, Chemo Therapy Failure, Clinical Trials, Clinical Trials, Drugs & Treatments, Early Access Program (EAP), Early/Expanded Access Programs, enzalutamide, Uncategorized, Understanding APC, Xtandi|0 Comments

Early Access Program Needs Your Help – Share Your Experiences to Insure A Continuing Program

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 [...]

By Malecare|2017-10-19T10:50:57-04:00August 27th, 2012|Advanced Prostate Cancer, Clinical Trials, Clinical Trials, Early/Expanded Access Programs, Uncategorized|0 Comments