FDA GRANTS FAST-TRACK STATUS TO PROVENGE
Dendreon reported that the 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 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 a primary Phase III efficacy study.
Provenge 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. The drug targets the prostate cancer antigen, prostatic acid phosphatase, which is found in approximately 95 percent of prostate cancers.