PCa immunotherapy drug receives 'complete response' nod from FDA

December 3, 2009

The FDA recently provided written acknowledgement that Dendreon Corp.?s amended biologics license application for sipuleucel-T (Provenge) is a complete response.

The FDA recently provided written acknowledgement that Dendreon Corp.’s amended biologics license application for sipuleucel-T (Provenge) is a complete response.

The FDA has assigned a Prescription Drug User Fee Act date of May 1, 2010, by which time it will respond to Dendreon’s amended application. Dendreon is seeking licensure for sipuleucel-T (Provenge) for men with metastatic castrate-resistant prostate cancer.

The FDA considers this to be a complete, class 2 resubmission following the action letter the company received in 2007. The application is based on data from the IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) study, which met its pre-specified primary endpoint, demonstrating a statistically significant improvement in overall survival in men with metastatic castrate-resistant prostate cancer. The resubmission also contains the remaining information requested by the FDA pertaining to chemistry, manufacturing, and controls.