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Phase III D9902B trial will serve as basis for Provenge approval.
2003 JUL 9 - (NewsRx.com & NewsRx.net) -- Dendreon Corporation (DNDN) announced that the company has received a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) indicating that its pivotal phase III trial, D9902B, will serve as the basis for a Biologics License Application for its lead investigational cancer vaccine, Provenge, for the treatment of androgen independent prostate cancer.
The SPA is a binding written agreement that provides for sponsors to receive official FDA evaluation on pivotal trials that will form the basis of final approval. Through this process, Dendreon worked closely with the FDA to ensure that the trial's design and planned analysis adequately addresses the clinical, statistical, and regulatory objectives.
"This is a significant achievement and confirms that the D9902B trial will serve as the basis for approval of our lead product Provenge," said Mitchell H. Gold, MD, chief executive officer of Dendreon. "We look forward to continuing our efforts to make Provenge available as soon as possible to the prostate cancer patients who may benefit from this therapy."
"A treatment like Provenge offers hope to the hundreds of thousands of men fighting prostate cancer," said John Page, president and CEO of Us Too! International, the world's oldest and largest prostate cancer advocacy organization. "There are few, if any, treatment options available for men with androgen independent prostate cancer."
"The SPA provision and binding agreement we now have with the FDA solidifies our regulatory pathway toward approval of Provenge," added Elizabeth Smith, Dendreon's vice president of regulatory affairs.
The double blind, placebo controlled phase III trial of Provenge is underway and will enroll approximately 275 patients at more than 60 medical centers throughout the United States. The current protocol for the phase III trial was amended following analysis of Dendreon's first completed phase III trial of Provenge, trial D9901. In that completed trial, patients with a Gleason score of 7 or below were shown to benefit most from Provenge treatment.
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