Our commitment to bringing patients better treatments that can extend survival with limited toxicity is what motivates us at Dendreon. We believe in the life-saving potential of autologous cellular immunotherapy (ACI). Early on, we recognized the power and potential of ACI to fight cancer. Thanks to that pioneering vision, our lead investigational ACI, PROVENGE® (sipuleucel-T), which targets prostate cancer, is now one of the most advanced cancer immunotherapy products in development.
In April 2009, we announced that the IMPACT study in men with advanced prostate cancer had met its primary endpoint of improving overall survival compared to a placebo control. The U.S. Food and Drug Administration had previously indicated that a positive analysis of overall survival from the IMPACT study would be sufficient to amend our Biologics License Application and support the efficacy claim for sipuleucel-T. After submitting our amended BLA in October 2009, sipulelucel-T was assigned a Prescription Drug User Fee Act (PDUFA) date of May 1, 2010.
Truly great products that make a lasting and real change require an almost zealous commitment and passion. We're deeply appreciative of the efforts of our clinical investigators, nurses, patients, patient advocacy groups and our own employees and advisors, all of whom share this commitment and passion.
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