Dendreon's Provenge gets nod from FDA c'ttee

US drugmaker Dendreon says that the US Food and Drug Administration's Office of Cellular, Tissue and Gene Therapies Advisory Committee recommended that the agency approve Provenge (sipuleucel-T), noting that there is substantial evidence of efficacy and safety of the drug for patients with asymptomatic, metastatic, androgen-independent (also known as hormone-refractory) prostate cancer. On the day of the news, March 30, shares in the Seattle-based drugmaker jumped 280% to $14.

Dendreon noted that, if approved for marketing by the FDA, the drug 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 the company anticipates a decision by May 15.

The Advisory Committee was asked if the submitted data established that sipuleucel-T (APC-8015) is reasonably safe and whether there is substantial evidence that the product is efficacious and voted 17 to 0 in favor of the safety of Provenge in response to the question and 13 to 4 in favor of its efficacy. Dendreon chief executive Mitchell Gold said that, "if approved, Provenge could become a breakthrough treatment for patients with advanced prostate cancer who currently have few treatment options."