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news.Dendreon Corporation has said the FDA will review the biologics license application for Provenge, its investigational active cellular immunotherapy for the treatment of prostate cancer.
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The submission is based primarily on an improvement in overall survival observed in a phase III study. Prostate cancer is the most common non-skin cancer in the US and the third most common cancer worldwide. The review will take place on March 29, 2007.
Dendreon completed the submission of its application for Provenge in November 2006, and the FDA accepted the filing and assigned priority review status for the application.
Priority review is granted to products that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease.
Based on the FDA’s designation of priority review for Provenge, Dendreon anticipates action approximately six months from the submission date.