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news.Dendreon has submitted the clinical and non-clinical sections of its rolling biologics license application seeking approval for Provenge in prostate cancer to the FDA.
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The rolling biologics license application (BLA) submission is seeking clearance to market Provenge (sipuleucel-T) for the treatment of asymptomatic patients with metastatic, androgen-independent (also known as hormone-refractory) prostate cancer. Dendreon plans to submit the chemistry, manufacturing and controls (CMC) section of the BLA later this year, which will complete the submission of the application.
The clinical section of the BLA contains the evidence supporting the safety and efficacy of Provenge for the treatment of men with advanced prostate cancer. In particular, this section of the BLA contains clinical trial data supporting the conclusion that Provenge confers an advantage in overall survival, without significant toxicity, to men with asymptomatic, metastatic, androgen-independent prostate cancer.
“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,” said Dr Mitchell Gold, president and CEO of Dendreon. “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.”
If approved, Provenge would become the first commercially available active immunotherapy (or therapeutic cancer vaccine), to treat advanced hormone-refractory prostate cancer.