Provenge to See Early Results

March 19, 2008

Dendreon hopes to get final results from its Phase III trial of Provenge immunotherapy for advanced prostate cancer a year earlier than anticipated after the FDA agreed to allow the trial’s protocol to be amended.

Last May, the FDA requested additional clinical data from Dendreon to support its efficacy claim for Provenge (sipuleucel-T) despite a vote by the Cellular, Tissues and Gene Therapies Advisory Committee in favor of approving the drug. The committee voted 13–4 that the product was effective and 17–0 that it was safe.

The FDA’s request led three congressmen to level accusations that conflicts of interest on the advisory committee might have led some of its members to send written requests to the FDA asking that the drug not be approved.

Interim results from the IMPACT study of Provenge still are expected later this year, but final results are now expected in the second half of next year rather than the second half of 2010, Dendreon said.