FDA Advisory Committee Gives a “Thumbs-Up” to PROVENGE Cancer Vaccine

March 30, 2007

Yesterday, FDA’s Cellular, Tissue and Gene Therapies Advisory Committee voted in favor of Dendreon Corp.’s PROVENGE (sipuleucel-T), an autologous active cellular immunotherapy intended to treat men with asymptomatic metastatic androgen independent prostate cancer.  The committee unanimously voted (17-0) that PROVENGE is reasonably safe for the intended population, and overwhelmingly voted (13-4) that the submitted data provide substantial evidence to establish the efficacy of the biologic, based on a demonstrated 4.5 month survival advantage over placebo in the follow-up period of a randomized, double-blind, placebo-controlled trial.  Equally importantly, the unique product characterization issues presented by cell therapy were discussed at yesterday’s meeting.  FDA is expected to make a final decision on the PROVENGE Biologic License Application by mid-May. 

If approved, PROVENGE would be the first autologous cancer cell therapy, and the first cancer immunotherapy approved by FDA.  According to a Dendreon press release, “If approved, PROVENGE could become a breakthrough treatment for patients with advanced prostate cancer who currently have few treatment options. . . . More than one million men in the United States have prostate cancer, with an estimated 218,890 new cases of prostate cancer diagnosed each year.”


Categories: FDA News