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FDA Law Weekly

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Cancer Gene Therapy



Dendreon Announces FDA's Cellular, Tissue and Gene Therapies Advisory Committee to Review Provenge for the Treatment of Asymptomatic, Metastatic, Androgen-Independent Prostate Cancer



March 15th, 2007

Dendreon Corporation (NASDAQ:DNDN) announced that the U.S. Food and Drug Administration's Office of Cellular, Tissue and Gene Therapies Advisory Committee will review the Biologics License Application (BLA) for PROVENGE (sipuleucel-T), the Company's investigational active cellular immunotherapy (ACI) for the treatment of asymptomatic, metastatic, androgen-independent (also known as hormone refractory) prostate cancer on March 29, 2007. The Center for Biologics Evaluation and Research (CBER) has oversight of the Cellular, Tissue and Gene Therapy Advisory Committee.

Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer...


Source: FDA Law Weekly (2007-03-15)

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