If approved for marketing by the FDA, Provenge would become the first active cellular immunotherapy and the first biologic approved to treat prostate cancer. The FDA will now review the advisory committee’s recommendations and Dendreon anticipates a decision on Provenge by May 15, 2007.
The committee was asked if the submitted data established that Provenge is reasonably safe and whether there is substantial evidence that the product is efficacious. The advisory committee voted 17 to 0 in favor of the safety of Provenge and 13 to 4 in favor of its efficacy.