ILEX Oncology (ILXO) Updates Clofarabine NDA With Encouraging Results; Additional Patient Data Resets FDA Action Date
10/19/2005 5:11:41 PM
ILEX(TM) Oncology Inc. (Nasdaq:ILXO) announced today that it has chosen to provide the U.S. Food and Drug Administration (FDA) with new patient data to support the New Drug Application (NDA) it submitted for clofarabine for the treatment of refractory or relapsed acute leukemia in children. The decision to update the filing was based on encouraging efficacy results from a cohort of additional patients. Based on the significant new data added to the original filing, the FDA has reset the Prescription Drug User Fee Act (PDUFA) response date to December 30, 2004.
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