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November 20, 2009
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According to Dendreon, the FDA's assignment of the PDUFA date in this case means the agency's goal is to respond to the company's amended BLA by then.
Should the FDA follow the data this time around, Provenge would be the first product in the new therapeutic class known as active cellular immunotherapies.
In a press release, Dendreon notes: "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."
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