The MDS Beacon™

FDA Declines To Approve Clolar As Treatment For Adult AML Patients – 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.  For more information, please see the Genzyme press release. For information on Clolar trials for MDS patients, please see the U.S. government’s Clinical Trials Web site.

MDS U.S. Patient And Family Forum – The Myelodysplastic Syndromes Foundation will be holding a Patient and Family Forum in Pittsburgh, PA on October 21. Guest speaker Dr. James Rossetti of the Western Pennsylvania Cancer Institute will provide important information for MDS patients and their families. The event is free, but registration is required. For more information about registering for the event or for a detailed listing of upcoming U.S. or international forums, please see the MDS Foundation Web site.

For a more detailed listing of MDS-related events, please check the MDS Beacon Events Calendar.