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news.The FDA has assigned priority review status to Dendreon's biologics license application for Provenge, its investigational drug for prostate cancer.
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Priority Review is granted to products that would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious disease. The status also speeds up the review process to within six months, whereas traditionally products can take up to a year to receive approval. The date for completion of review by the FDA of the Provenge application is May 15, 2007.
The biologics license application 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
“Clinical trials have shown that Provenge increases survival and is generally well tolerated in men with late-stage prostate cancer, a highly prevalent disease for which there are currently few available treatment options,” said Mitchell Gold, president and CEO of Dendreon.