FDA Approves New Life Prolonging Drug For Men With Late Stage Prostate Cancer - Xtandi
Posted Sep 03 2012 2:22am
There are already a couple of other drugs in this group and the FDA only took 3 months to review it. Zytiga from Johnson and Johnson will be the big competitor here although they have not been compared to each other and this drug does not require the steroid drug to be given at the same time for treatment. The cost is up there though with being over $7000.00 a month and it is approved for use once Docetaxel has been tried. Instead of stopping the production of the hormone testosterone, it blocks the actions. BD
In clinical trials, men who received the drug, which was previously known as MDV3100, lived a median of 18.4 months, nearly five months longer than the median of 13.6 months for those who received a placebo.
While the approval was not a surprise, its timing was. The F.D.A. approved the drug after only a three-month review, three months ahead of the deadline in late November. This is fairly rare, although a number of other cancer drugs have been approved at least a month ahead of deadline in recent years.
Xtandi and Zytiga have not been compared head-to-head in a clinical trial. But some analysts say Xtandi would have an edge because it does not have to be given with prednisone, a steroid , to minimize side effects, as Zytiga does.