Dendreon Announces FDA Grants Fast Track Status for Provenge
PROVENGE Significantly Extends Prostate Cancer Specific Survival in Advanced Prostate Cancer
SEATTLE, WA, November 7, 2005  Dendreon Corporation (Nasdaq: DNDN) today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track review status to PROVENGE® (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.
Earlier:
Dendreon's Phase 3 Trial Shows Provenge Vaccine Extends Survival in Patients with Advanced Prostate Cancer Oct 28, 2004
Followup:
Provenge prostate cancer vaccine linked to longer survival for asymptomatic hormone refractory stage. June 28, 2006
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].
