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Immunotherapy Provenge Receives Fast Track Designation from FDA
The designation of Provenge under Fast Track means that the FDA will take appropriate actions to expedite the development and review of a potential Biologics License Application for approval of Provenge in the target indication. Specifically, Fast Track designation allows for a rolling submission of a potential Biologics License Application with the FDA for Provenge and ordinarily provides for a priority review. A priority review as defined by the FDA is a six-month review cycle.
Provenge is currently in a pivotal double blind placebo-controlled Phase 3 trial seeking to confirm previous results that indicate the product may delay progression of disease and the development of disease-related pain. Dendreon has received a positive assessment from the FDA under the Special Protocol Assessment (SPA) provision indicating the trial, D9902B, may serve as the basis for a Biologics License Application for Provenge.
"The designation of Provenge as a Fast Track program by the FDA validates its promise to address a serious unmet medical need for the treatment of advanced, asymptomatic androgen independent prostate cancer," said Mitchell H. Gold, M.D., Chief Executive Officer. "This designation combined with the receipt of the SPA agreement for our pivotal Phase 3 trial and last year's successful review of the product characterization are significant regulatory milestones and mechanisms that may increase the speed with which Provenge can be brought to market."
Dendreon submitted the Fast Track application with the FDA for Provenge based on positive results from the double blind, placebo-controlled Phase 3 trial, D9901. Results of the trial demonstrated significant clinical benefit from Provenge treatment for men with androgen independent prostate cancer (AIPC) with a Gleason score of 7 or less. For these men, the probability of remaining progression free and free of cancer-related pain while on the study was more than two times higher than for patients treated with placebo. Supporting these clinical results were findings confirming the mechanism of action based on the immune response stimulated by Provenge treatment. Among men treated with Provenge, those with a Gleason score of 7 or less demonstrated a T-cell mediated immune response 7-fold greater than the immune response in men with a Gleason score of 8 or more. Treatment was well tolerated, with mild infusion-related fevers and chills the most common adverse events.
Provenge Pivotal Trial
A double blind, placebo controlled Phase 3 trial of Provenge is underway at medical centers throughout the United States. To be eligible for the study, patients must have metastatic prostate cancer that has progressed following hormone therapy and have a Gleason score of 7 or less. Patients must also be free of cancer-related pain.
Information on Dendreon's clinical trials is available at www.dendreon.com.
Provenge is designed to stimulate a person's immune system against prostate cancer. It is developed through Dendreon's proprietary Antigen Delivery Cassette(TM) technology, which utilizes a recombinant form of an antigen found in 95 percent of prostate cancers, prostatic acid phosphatase (PAP).
About Prostate Cancer
Prostate cancer is the leading cancer diagnosed among men in the United States. More than one million men in the United States have prostate cancer, with 189,000 cases diagnosed and 30,200 deaths in 2002. There is currently no available therapeutic treatment for asymptomatic metastatic androgen independent prostate cancer.
About Gleason Score
The Gleason score is the most commonly used prostate cancer scoring system and is considered one of the most important prognostic indicators for prostate cancer. The score is based on tissue findings throughout the prostate that correlate with the aggressiveness of a tumor. High Gleason scores are indicative of aggressive cancers and are not associated with a favorable prognosis. In the androgen independent patient population approximately 75 percent of the patients have a Gleason score of 7 or less.
Source: Dendreon Corporation