Dendreon announces completion of FDA submission
Update November 13, 2006
Dendreon Corporation announced on November 13, 2006 that the final portion of the Biologics License Application (BLA) for PROVENGE® (sipuleucel-T) has been submitted to the U.S. Food and Drug Administration (FDA), completing its rolling submission that began in August 2006. Dendreon is seeking marketing approval for PROVENGE for the treatment of asymptomatic, metastatic, androgen-independent (also known as hormone-refractory) prostate cancer. As part of the PROVENGE BLA submission, Dendreon has requested a Priority Review designation from the FDA, which, if granted, would give the FDA six months from the Agency’s receipt of the submission to take action on the application.
The submission of the BLA for the first active cellular immunotherapy for cancer is a major milestone for the Company and the prostate cancer community. The survival benefit observed in clinical trials, combined with the favorable safety profile of PROVENGE form the basis of the submission. Dendreon looks forward to working with the FDA to make PROVENGE available to the many men with advanced prostate cancer who currently have few treatment options.
PCRI was one of the first to publish an article on “Dendritic Cells Providing Key to Prostate Cancer Immunotherapy” in our October 2001 issue of PCRI Insights and published an “Update on Provenge Trials” in the Nov 2003 issue.