Dendreon receives fast track designation for Provenge

The FDA has designated Dendreon's investigational immunotherapy Provenge as a fast track development program for the treatment of asymptomatic, metastatic, androgen independent prostate cancer.

The designation of Provenge means that the FDA will take appropriate actions to expedite the development and review of a potential biologics license application (BLA) for approval of Provenge in the target indication. Specifically, fast track designation allows for a rolling submission of a potential BLA with the FDA for Provenge and ordinarily provides for a priority review. A priority review as defined by the FDA is a six-month review cycle.

Provenge is currently in a pivotal double blind placebo-controlled Phase III trial seeking to confirm previous results that indicate the product may delay progression of disease and the development of disease-related pain. Dendreon has received a positive assessment from the FDA under the special protocol assessment (SPA) provision indicating the trial, D9902B, may serve as the basis for a BLA for Provenge.

'The designation of Provenge as a fast track program by the FDA validates its promise to address a serious unmet medical need for the treatment of advanced, asymptomatic androgen independent prostate cancer,' said Dr Mitchell Gold, chief executive officer. 'This designation combined with the receipt of the SPA agreement for our pivotal Phase III trial and last year's successful review of the product characterisation are significant regulatory milestones and mechanisms that may increase the speed with which Provenge can be brought to market.'