Dendreon Receives FDA Acknowledgement of Complete Response- PDUFA Date Assigned as May 1, 2010
Fri, 11/20/2009 - 4:01am
Dendreon Corporation today announced that the FDAprovided written acknowledgement that the Company's amended Biologics LicenseApplication (BLA) for PROVENGE (sipuleucel-T) is a complete response. TheFDA 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 seekinglicensure for PROVENGE for men with metastatic castrate-resistant prostatecancer (CRPC). The FDA considers this to be a complete, Class 2 Resubmission followingthe action letter the company received in 2007. The BLA includes data fromthe IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) trial, whichwas conducted under a Special Protocol Assessment agreement with the FDA. TheIMPACT study met its pre-specified primary endpoint demonstrating astatistically significant improvement in overall survival in men withmetastatic CRPC. The resubmission also contains the remaining informationrequested by the FDA pertaining to chemistry, manufacturing and controlssection of the BLA for PROVENGE. If approved by the FDA, PROVENGE would represent the first product in anew therapeutic class known as active cellular immunotherapies.