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Treatment for Prostate Cancer

Update: Provenge Now FDA Approved - April 29, 2010

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

SEATTLE, March 1, 2007 -- Dendreon Corporation today 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 worldwide. More than one million men in the United States have prostate cancer, with an estimated 218,890 new cases of prostate cancer diagnosed each year. More than 27,000 men die each year of the disease.

The BLA submission is based primarily on an improvement in overall survival observed in Study D9901, a multi-center, randomized, double-blind, placebo-controlled Phase 3 Study. The results from D9901 were published in the July issue of the Journal of Clinical Oncology.

Dendreon completed the submission of its BLA for Provenge in November 2006, and the FDA accepted the filing and assigned Priority Review status for the application in January 2007. 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, the Company anticipates action by the FDA approximately six months from the submission date, or by May 15, 2007.

About Provenge

Provenge is an investigational product that may represent the first in a new class of active cellular immunotherapies that are uniquely designed to stimulate a patient's own immune system. Provenge is in late-stage clinical development for the treatment of patients with advanced prostate cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.

Source: Dendreon Corporation

Posted: March 2007

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