Dendreon Corporation (Nasdaq: DNDN) has submitted the clinical and non-clinical sections of the rolling submission of its USFDA Biologics License Application (BLA) of PROVENGE® (sipuleucel-T) for the treatment of asymptomatic patients with metastatic, androgen-independent (also known as hormone-refractory) prostate cancer.
The BLA’s clinical section contains the safety and efficacy evidence of PROVENGE® for the treatment of men with advanced prostate cancer, specifically the clinical trial data supporting the conclusion that PROVENGE confers an advantage in overall survival to men with asymptomatic, metastatic, androgen-independent prostate cancer, without significant toxicity.
Dendreon Corp will 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®.
According to Mitchell H. Gold, M.D., president and chief executive officer of Dendreon:
"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. 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."
PROVENGE® (sipuleucel-T) is Dendreon Corp.’s investigational product designed to stimulate a patient's own immune system to recognize and destroy prostate cancer cells. Currently being evaluated for the treatment of patients with early- and advanced-stage prostate cancer, PROVENGE® is under USFDA Fast Track Review status.
Once approved, PROVENGE® will become the first commercially available active immunotherapy (sometimes referred to as therapeutic cancer vaccine) to treat advanced hormone-refractory prostate cancer.
Read the full press release.
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