Celgene Corporation (Nasdaq:CELG) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review classification to its Supplemental New Drug Application (sNDA) regarding ISTODAX (romidepsin) for injection for the treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy. The Prescription Drug User Fee Act (PDUFA) date is June 17, 2011. Priority Review is granted to a pharmaceutical product that, if approved, would meet an unmet medical need for a serious and life-threatening condition.
The ISTODAX sNDA submission is based upon the safety and efficacy results of a Phase II, multicenter, international, open-label study of ISTODAX in progressive or relapsed PTCL following prior systemic therapy. Clinical data from this study were presented during the December 2010 meeting of the American Society of Hematology (ASH).
ISTODAX is not approved as a treatment in progressive or relapsed PTCL.