Breaking News – FDA Approves another New Treatment for Late Stage Advanced Prostate Cancer – Xtandi (MDV3100)

The U.S. Food and Drug Administration today, August 31, 2012 approved Xtandi® (MDV3100) (enzalutamide) capsules to treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone. Approved for prostate cancer patients previously treated with chemotherapy, Xtandi was reviewed under the FDA’s priority review [...]

A FDA Approval for Zytiga Before Chemotherapy – On the Horizon

On Wednesday, Johnson & Johnson said that the FDA will conduct a fast review of Zytiga as a treatment for men with advanced prostate cancer who have not received chemotherapy. The Food and Drug Administration has agreed to conduct a six-month review of Zytiga which should be completed in mid-December, 2012. According to representatives from [...]

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 [...]

Travel Notice

I wanted to let everyone know that over the next two weeks my posts might become few and far between. Iaa am traveling with my family in Alaska where my ability to find either internet or cell connections has become difficult. I will attempt to find an occasional connection and put something up. I will [...]

By |2012-08-20T02:06:49-04:00August 20th, 2012|Advanced Prostate Cancer, Uncategorized|1 Comment

Four New Sites Added to the MDV3100 (Enzalutamide) Early Access Trial

The Early/Expanded Access Committee has informed me that four additional sites have been added to the trial so there are now 23 States that have an expanded access trial of MDV3100 available to men with advanced prostate cancer. The trial is designed to monitor the safety of the drug in men with progressive castration-resistant advanced [...]

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