FDA’s Office of Cellular, Tissue and Gene Therapies Advisory Committee recommended to the agency that there is substantial evidence of efficacy and safety of Provenge (sipuleucel-T), made by Dendreon Corporation of Seattle, for treating patients with hormone refractory prostate cancer.
After the agency assigned priority review status to the experimental therapy (FDA News, March 2007), the advisory committee unanimously agreed that the submitted data established that sipuleucel-T is reasonably safe, and voted 13-4 in favor of its efficacy. If approved for marketing, Provenge would be the first active cellular immunotherapy for prostate cancer.
The FDA was expected to make a decision on the drug by May 15.
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