FDA acknowledges Dendreon's amended BLA for PROVENGE as a complete response

Nov 20 2009

Dendreon Corporation (Nasdaq: DNDN) today announced that the U.S. Food and Drug Administration (FDA) provided written acknowledgement that the Company's amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T) is a complete response. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of May 1, 2010, by which time it will respond to Dendreon's amended BLA. Dendreon is seeking licensure for PROVENGE for men with metastatic castrate-resistant prostate cancer (CRPC).

The FDA considers this to be a complete, Class 2 Resubmission following the action letter the company received in 2007. The BLA includes data from the IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) trial, which was conducted under a Special Protocol Assessment agreement with the FDA. The IMPACT study met its pre-specified primary endpoint demonstrating a statistically significant improvement in overall survival in men with metastatic CRPC. The resubmission also contains the remaining information requested by the FDA pertaining to chemistry, manufacturing and controls section of the BLA for PROVENGE.

If approved by the FDA, PROVENGE would represent the first product in a new therapeutic class known as active cellular immunotherapies.

SOURCE Dendreon Corporation