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Fast Track Review Status Granted to Provenge
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.
Source: Dendreon Corporation