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 Janssen Research & Development, a unit of Johnson & Johnson, said that it had asked the FDA to approve Zytiga as a treatment for prostate cancer that has metastasized and has few or no symptoms following the failure of androgen-deprivation therapy (ADT). Zytiga was approved in April of 2011for use in combination with the steroid prednisone in men who have failed chemotherapy.
In practice, many men have already been using Zytiga, off label, prior to chemotherapy failure.
Joel T. Nowak, M.A., M.S.W.