Product ListOnline Service |
FDA Declines To Approve clofarabine As Treatment For Adult AML Patients
Nov 7, 2009 9:33:24 PM
On October 6, Genzyme Corporation reported that the FDA has declined to approve the company's application to market Clolar (clofarabine) as a treatment for adult acute myeloid leukemia (AML) patients. Clolar is currently approved for the treatment of children with acute lymphoblastic leukemia who have relapsed or failed to respond to at least two other drugs. Genzyme says that the FDA is recommending a randomized, controlled clinical study of Clolar in adult AML patients as a condition for approving Clolar's use in those patients, and that the company plans to meet with the FDA to discuss next steps. Genzyme is also investigating Clolar as a treatment for MDS and several other conditions.
|
.gif)
By 