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Investigational Drug for Advanced Melanoma Receives FDA Priority Review

Earlier this week, pharmaceutical company Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted a priority review for Ipilimumab, an investigational treatment,  for adult patients with advanced melanoma who have been previously treated.  Ipilimumab is a human monoclonal antibody that enables the body’s immune system to attack melanoma cells.  Priority review is given to drugs that “offer major advances in treatment, or provide a treatment where no adequate therapy exists,” according to the FDA and means that the FDA will render a decision on approval within six months.  The projected date for this decision is December 25, 2010.

The Melanoma Research Foundation (MRF) is pleased to see the accelerated review time for approval, given that a decade has passed since a new therapy was approved for advanced melanoma.  The MRF continues to advocate for new treatment options for patients in supporting investigational research and improved collaborations through the MRF Breakthrough Consortium.