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Fast Track Designation Granted for Cloretazine in Elderly Poor-Risk Acute Myelogenous Leukemia
Under the FDA Modernization Act of 1997, Fast Track designation allows the FDA to accept, on a rolling basis, portions of a marketing application prior to the completion of the final registration package. Fast Track designation may potentially expedite the review of a drug that is intended for the treatment of a serious life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition.
Alan Kessman, Chief Executive Officer, stated, "We are pleased that the FDA has granted an additional fast track designation to Cloretazine(R). Based on our Phase II data in this indication, we believe that Cloretazine(R) has potential for the treatment of this unmet medical need. We look forward to meeting with the FDA to discuss the specifics of the path forward."
Source: Vion Pharmaceuticals, Inc.