Genzyme Drug Fails to Win FDA Nod
Luke Timmerman10/6/09
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: GENZ) lacked data. The product is already approved for a smaller population of children with leukemia.
Luke Timmerman is the National Biotech Editor of Xconomy, and the Editor of Xconomy Seattle. E-mail him at ltimmerman@xconomy.com or follow him on Twitter at twitter.com/ldtimmerman.
