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Provenge

Generic name: sipuleucel-T
Treatment for: Prostate Cancer

Update: Provenge Now FDA Approved - April 29, 2010

Dendreon Submits Clinical and Non-Clinical Sections of Rolling BLA to FDA for Provenge

SEATTLE, August 24, 2006 -- Dendreon Corporation today announced that the Company has submitted the clinical and non-clinical sections of the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Provenge (sipuleucel-T) for the treatment of asymptomatic patients with metastatic, androgen-independent (also known as hormone-refractory) prostate cancer. The Company plans to submit the chemistry, manufacturing and controls (CMC) section later this year, which will complete the submission of the BLA to the FDA for approval to market Provenge.

The clinical section of the BLA contains the evidence supporting the safety and efficacy of Provenge for the treatment of men with advanced prostate cancer. In particular, this section of the BLA contains the clinical trial data supporting the conclusion that Provenge confers an advantage in overall survival, without significant toxicity, to men with asymptomatic, metastatic, androgen-independent prostate cancer.

"Prostate cancer is the second leading cause of cancer death in American men and remains a serious unmet medical need with few effective treatment options," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "Based upon the results of our clinical trials, we believe that Provenge has a highly favorable benefit-to-risk profile, and we are focused on working closely with the FDA so that Provenge can be made available to help prostate cancer patients."

The FDA has granted Fast Track review status to Provenge enabling Dendreon to submit its BLA on a rolling basis so the FDA can review sections before receiving the complete submission. If approved, Provenge would become the first commercially available active immunotherapy, sometimes referred to as therapeutic cancer vaccine, to treat advanced hormone-refractory prostate cancer.

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 232,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year of the disease.

About Provenge

Provenge (sipuleucel-T) is an investigational product that is designed to stimulate a patient's own immune system to recognize and destroy prostate cancer cells. It is currently being evaluated for the treatment of patients with early- and advanced-stage prostate cancer. In clinical studies, patients typically are randomized to receive three infusions of Provenge or placebo over a one-month period as a complete course of therapy.

A double-blind, placebo-controlled Phase 3 Study (D9901) published in the July 2006 issue of the Journal of Clinical Oncology found that the group of asymptomatic men with metastatic, androgen-independent prostate cancer who received Provenge had a median survival time 4.5 months longer than the median survival seen in the group that had been assigned to receive placebo. For the men who received Provenge, there was a 41 percent overall reduction in the risk of death (p-value = 0.010; HR = 1.7). In addition, 34 percent of patients receiving Provenge were alive 36 months after treatment compared to 11 percent of patients randomized to receive placebo.

Treatment with Provenge was generally well tolerated. In controlled clinical trials, the most common adverse reactions associated with Provenge were chills, fever, headache, fatigue, shortness of breath, vomiting and tremor. These events were primarily low grade events, with a short duration lasting 1 to 2 days following infusion.

About Active Immunotherapy

Active immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity. To develop its active immunotherapy, Dendreon utilizes proprietary technology to modify, or engineer, tumor antigens as recombinant proteins. Dendreon combines these recombinant proteins with a patient's own immune system cells so that the tumor antigens are recognized by the immune system, generating an antitumor response.

Source: Dendreon Corporation

Posted: August 2006

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