Dendreon must wait to May next year to hear FDA decision on Provenge

US biotechnology firm Dendreon says that the US Food and Drug Administration as provided written acknowledgement that the company's amended Biologics License Application for Provenge (sipuleucel-T) is a complete response and the agency 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 approval of the vaccine 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 and also the first drug that loss-making Dendreon will bring to the market.

Assuming the timeline is adhered to, the potential approval of Provenge could not come at a more opportune time for Dendreon, says CNBA news, which also points out that the FDA can be unpredictable. That's because the scientific and medical meetings for the company's most targeted markets, the American Urological Association and the American Society of Clinical Oncology, are being held back-to-back around the end of May, beginning of June. Dendreon could launch Provenge with a huge splash at those events, the news service notes.