According to a Reuters report, a spokeswomen from the FDA said yesterday that, “There is not going to be an additional advisory committee meeting” about the current application for the approval of Provenge. The FDA has the right to convene another meeting to discuss the results of the IMPACT trial, but it now looks as if they will not exercise this option.
Although this does not mean that there has been any decision yet, it bolsters my hope that the FDA will finally approve Provenge for use by men with advanced metastatic prostate cancer.
The FDA has indicated they will release their decision before May 1, 2010. Wouldn’t it be nice to hear from them before May, how about today, March 3?
Joel T Nowak, MA, MSW