The FDA has assigned priority review status to the Biologics License Application for Provenge (sipuleucel-T), an investigational immunotherapy for asymptomatic, metastatic, androgen-independent (also known as hormone refractory) prostate cancer.
The priority status is based primarily on the results of a multicenter, randomized phase 3 study showing an improvement in overall survival, which was published in the Journal of Clinical Oncology (2006;24:3089-3094).
Priority review is given to products that, if approved, would significantly improve the safety or effectiveness of the treatment, diagnosis, or prevention of a serious or life-threatening disease. The target date for completion of review is May 15, 2007. Provenge is made by Dendreon Corporation of Seattle.