We all manage to accumulate prescription and non-prescription medications that we no longer need. They can sit in our medicine chests accumulating dust or even be stolen and sold for illegal use. Some people just throw them away in their garbage cans and others flush them down the toilet. Al three of these solutions are [...]
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 [...]
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 [...]
My very dear friend and advocate supreme, Jan Manarite, from PCRI has sent me an update on MDV3100 (enzalutamide). As usual her information is important, so I thought I would pass it on today. • She points out that once the FDA approves MDV3100 (I am going to work on the assumption that it will [...]
Recently, it was announced that there was a submission by Astellas and Medivation to the European Regulatory Agency for Enzalutamide (MDV-3100) for the treatment of men with advanced prostate cancer post-chemotherapy The basis of the submission was the pivotal phase 3 AFFIRM study. The Marketing Authorization Application (MAA) that was made to the European Medicines [...]