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Genzyme Asks FDA To Approve Drug for Acute Myeloid Leukemia

Genzyme said today it has applied for FDA approval of clofarabine (Clolar) for patients over age 60 with acute myeloid leukemia, in addition to its existing use for acute lymphoblastic leukemia. The Cambridge,MA-based biotech company (NASDAQ: GENZ) has asked for an expedited six-month review of the new use, which means the treatment could be approved for sale in the U.S. in the first half of 2009. The product, which Genzyme obtained through the $345 million acquisition of Bioenvision last year, has potential to generate peak annual sales of $600 million if it is cleared for multiple forms of leukemia, Genzyme said.

Luke Timmerman is the National Biotechnology Editor for Xconomy. You can email him at ltimmerman@xconomy.com or call 206-624-2374.

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