Genzyme awaits FDA approval for leukemia treatment

CAMBRIDGE, Mass. A Food and Drug Advisory Committee considered whether to approve a drug for treating acute myeloid leukemia, the drug’s manufacturer announced.

Genzyme Corp. said the FDA’s Oncologic Drugs Advisory Committee decided Tuesday on whether to recommend approval for Clolar (clofarabine) as a treatment for AML in patients ages 60 and older. As of Sept. 1, the committee determined that more data is needed to establish its safety for older patients. An FDA advisory committee’s recommendation does not guarantee approval for a drug, but will be taken into consideration when the FDA decides whether to approve it.

Clolar is already approved for treating acute lymphoblastic leukemia. The last induction therapy for newly diagnosed AML patients was approved in 1990.

“Most AML patients who are 60 years or older and have unfavorable prognostic factors do not receive conventional induction therapy because of the lower response rates and high treatment-related mortality,” Genzyme Oncology and Multiple Sclerosis president Mark Enyedy said in a statement. “The clofarabine data in this patient population demonstrate durable complete remissions with low treatment-related mortality and suggest that Clolar could provide an important new therapeutic option for these patients.”