SEATTLE, Nov. 7 /PRNewswire-FirstCall/ -- Dendreon Corporation today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track review status to PROVENGE(R) (sipuleucel-T) for its proposed use in the treatment of asymptomatic men with metastatic, androgen-independent prostate cancer.
The FDA determined that PROVENGE meets the criteria for Fast Track designation in that PROVENGE shows the potential to improve survival in the intended patient population of men with asymptomatic, metastatic, androgen- independent prostate cancer. The potential of PROVENGE to provide a survival benefit was based on results from the primary Phase 3 efficacy study, D9901, and supporting data from D9902A, which were recently discussed with the FDA in a pre-BLA meeting.
Under the FDA Modernization Act of 1997, designation as a Fast Track drug product provides for expedited regulatory review for new drugs demonstrating the potential to address unmet medical needs for the treatment of serious or life-threatening conditions. Under Fast Track, Dendreon is now eligible to submit a U.S. biologics license application (BLA) on a rolling basis. This permits the FDA to review sections of the BLA in advance of receiving the complete submission.
“Fast Track designation for PROVENGE is an important step and acknowledgement of the potential for this active cellular immunotherapy to impact survival in men with advanced prostate cancer,” said Mitchell H. Gold, M.D., Dendreon’s president and chief executive officer. “We look forward to working closely with the FDA to bring what could be the first active immunotherapy agent to market as soon as possible to help the many men with advanced prostate cancer who have few appealing treatment options.”
Prostate cancer is the number one non-skin cancer in the United States. More than one million men in the United States have prostate cancer, with an estimated 220,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year from the disease.
About PROVENGE (sipuleucel-T)
PROVENGE (sipuleucel-T) is an investigational product that may represent the first in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient’s own immune system. ACIs hold promise because they may provide patients with a meaningful survival benefit with low toxicity. PROVENGE targets the prostate cancer antigen, prostatic acid phosphatase (PAP), which is found in approximately 95% of prostate cancers. PROVENGE is in late-stage clinical development for the treatment of patients with early-stage and advanced prostate cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.
About Dendreon
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the development of innovative cancer treatments. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon’s product pipeline also includes monoclonal antibody and small molecule product candidates. Dendreon has research and development alliances with Genentech, Inc., Abgenix, Inc. and Dyax Corp. For more information about the company and its programs, visit www.dendreon.com.
Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of Provenge to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of a clinical trial for Provenge will not support an application for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for Provenge or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of Provenge, our dependence on the efforts of third parties, including collaborators, and our dependence on intellectual property. Further information on the factors and risks that could affect Dendreon’s business, financial condition and results of operations is contained in Dendreon’s public disclosure filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.
Dendreon Corporation
CONTACT: Monique Greer, Sr. Director, Corporate Communications of DendreonCorporation, +1-206-829-1500
Web site: http://www.dendreon.com/
