Positive data sufficient for Provenge approval

USA-based biotechnology firm Dendreon says it has received notification from the Food and Drug Administration that positive interim, or final analysis of, survival data from an ongoing trial of its immunostimulatory agent Provenge (sipuleucel-T) would be sufficient to address the request for additional efficacy information detailed in an approvable letter issued earlier this year (Marketletter May 14).

The FDA's Cellular Tissue and Gene Therapies Advisory committee voted 17 to nil that the product was safe, but only 13 to four that it was effective. The agency's latest guidance, issued during a meeting with Dendreon, indicated that positive survival data from the IMPACT trial, assessing the agent in the treatment of prostate cancer, would satisfy the committee's efficacy requirements.

Boosts survival time by 4.5 months