FDA Advisory Committee Recommends Approval of Dendreon's Provenge BLA

Dendreon announced that the FDA's Cellular, Tissue and Gene Therapies Advisory Committee recommended to the FDA that there is substantial evidence of the efficacy and safety of Provenge as a treatment for patients with asymptomatic, metastatic, androgen-independent (also known as hormone-refractory) prostate cancer.

If approved for marketing by the FDA, Provenge (sipuleucel-T) 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, the company said, anticipating a decision by May 15.

The committee was asked if the submitted data established that sipuleucel-T is reasonably safe and whether there is substantial evidence that the product is efficacious, voting 17-0 in favor of the safety and 13-4 in favor of efficacy.

The Provenge biologics license application (BLA) is based primarily on an improvement in overall survival observed in Study D9901, a multicenter, randomized, double-blind, placebo-controlled, Phase III study. The results from D9901 were published in the July 2006 issue of the Journal of Clinical Oncology. Dendreon submitted the BLA in November 2006, and the FDA granted priority review status to the application.