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: [[ticker: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.

Author: Luke Timmerman

Luke is an award-winning journalist specializing in life sciences. He has served as national biotechnology editor for Xconomy and national biotechnology reporter for Bloomberg News. Luke got started covering life sciences at The Seattle Times, where he was the lead reporter on an investigation of doctors who leaked confidential information about clinical trials to investors. The story won the Scripps Howard National Journalism Award and several other national prizes. Luke holds a bachelor’s degree in journalism from the University of Wisconsin-Madison, and during the 2005-2006 academic year, he was a Knight Science Journalism Fellow at MIT.