ILEX Oncology, Inc. (ILXO) Release: FDA Advisory Committee Recommends Accelerated Clofarabine Approval For Most Common Pediatric Leukemia
10/19/2005 5:12:20 PM
ILEX(TM) Oncology, Inc. (Nasdaq:ILXO) announced today that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration positively endorsed clofarabine for the treatment of refractory or relapsed acute lymphoblastic leukemia (ALL). The panel advised conducting additional studies with clofarabine in acute myeloid leukemia (AML) before recommending an approval in this harder-to-treat leukemia, for which the Company also submitted data. Under the Prescription Drug User Fee Act, the FDA has until December 30, 2004 to complete the review of the clofarabine New Drug Application (NDA). The proposed branded name for clofarabine in North America is CLOLAR(TM).