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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 [...]

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 [...]

Breaking News- MDV-3100 Starts an Expanded Access Program in the United 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 [...]

Announcing Early Access To Alpharadin (Radium-233 Chloride)

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 [...]

Current Update on the Abiraterone Expanded Access Trial

The latest from Jan Manarite of PCRI about the getting early access to Abiraterone for men with advanced prostate cancer and who have failed chemotherapy: Abiraterone expanded Access Trial Site Contact Info – 2/7/11 (800) 457-6399 M-F, 9am –5pm, EST TRIAL link: http://www.clinicaltrials.gov/ct2/show/NCT01217697?term=abiraterone&recr=Open&rank=6 Basic Criteria: 1. testosterone less than 50 2. metastatic 3. no brain [...]

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