The FDA turned down Genzyme’s application to market clofarabine (Clolar) for patients over age 60 with acute myeloid leukemia, saying the Cambridge, MA-based company should conduct another randomized, controlled clinical trial. The agency’s decision comes about a month after one of its advisory panels recommended the drug not be cleared for the new group of patients, saying Genzyme (NASDAQ: [[ticker:GENZ]]) lacked data. The product is already approved for a smaller population of children with leukemia.
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.
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