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news.Dendreon is to submit a marketing application to the FDA for Provenge, the company's investigational immunotherapy, for the treatment of advanced prostate cancer.
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This decision follows a recent pre-biologics license application (BLA) meeting in which the company reviewed safety and efficacy data with the FDA from its two completed phase III clinical trials of Provenge in patients with advanced prostate cancer.
The outcome of these discussions determined that there was sufficient study data to serve as the clinical basis of a BLA submission for Provenge.
“Our decision to move forward with a BLA submission is based on feedback we have received from the FDA in a recent pre-BLA meeting,” said Dr Mitchell Gold, Dendreon’s president and chief executive officer. “We look forward to working closely with the FDA to bring what could be the first cancer immunotherapy agent to market for the many men with advanced prostate cancer who have few appealing treatment options.”