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Chronic Myeloid Leukemia
ChemGenex announces granting of Fast Track status for Ceflatonin by U.S. FDA
December 11th, 2006
ChemGenex Pharmaceuticals (CXS; CXSP) announced that its investigational drug Ceflatonin (homoharringtonine, HHT) has been awarded Fast Track status by the U.S. Food and Drug Administration (FDA). The Fast Track designation covers Ceflatonin for the treatment of patients with chronic, accelerated and blast-phase chronic myeloid leukemia (CML) who have failed imatinib mesylate (Gleevec) and have the T315I bcr-abl point mutation. The Fast Track designation will enable ChemGenex to file a New Drug Application (NDA) on a rolling basis as data becomes available. This permits the FDA to review the filing as it is received, rather than waiting for the...
Source: Obesity & Diabetes Week (2006-12-11)
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