Acute Lymphoblastic Leukemia

U.S. FDA committee recommends accelerated clofarabine approval for ALL

Published in Blood Weekly, December 30th, 2004

ILEX Oncology, Inc., (ILXO) announced that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) 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...

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Source: Blood Weekly (2004-12-30)

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