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news.Vion Pharmaceuticals has received fast track designation from the FDA for its anticancer agent Cloretazine for induction treatment of patients over 60 years of age with poor-risk acute myelogenous leukemia.
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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. The 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, CEO, stated, “We are pleased that the FDA has granted an additional fast track designation to Cloretazine. Based on our phase II data in this indication, we believe that Cloretazine 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.”
This is the second indication for which Cloretazine has received a fast track designation.