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 [...]

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 [...]

The Debate Continues, Is IAD or CAD Superior for the Treatment of Men with Castrate Resistant Prostate Cancer?

A new randomized study (FinnProstate Study VII) on the merits of intermittent androgen deprivation (IAD) compared to continuous androgen therapy (CAD) contradicts the recent revelations from the last ASCO presentation (Hussain et.al) where the clear conclusion was that CAD was superior to IAD. At the ASCO conference Dr. Hussain’s study concluded that IAD was significantly [...]

No Reduction in Mortality for Men with Localized Prostate Cancer who had a Prostatectomy

In an updated study published in the New England Journal of Medicine men who had a radical prostatectomy did not enjoy the experience of a reduced all-cause mortality or prostate cancer mortality compared with those men who had only observation through several years of follow-up. The subject men had localized prostate cancer often detected by [...]

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