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news.The FDA has granted fast track review status to Dendreon's drug candidate, Provenge, for its proposed use in the treatment of asymptomatic men with metastatic, androgen-independent prostate cancer.
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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 US biologics license application on a rolling basis. This permits the FDA to review sections of the application in advance of receiving the complete submission.
“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,” Dr Mitchell Gold, Dendreon’s president and CEO.