Genzyme Corporation has filed a supplemental New Drug Application (sNDA) for the use of their agent Clolar® (clofarabine) in the treatment of adults with acute myeloid leukemia (AML). Specifically, the sNDA seeks approval for the use of Clolar as a single agent in patients 60 years or older who have at least one unfavorable prognostic factor with previously untreated AML.
Clolar is already approved for the treatment of acute lymphoblastic leukemia (ALL) in relapsed and refractory pediatric patients between the ages of one to 21 years who have received at least two prior treatments.
Genzyme Corporation has requested priority review of the sNDA, which, if granted, could result in approval for the expanded indication by 2009.
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