Genzyme pulls European leukemia drug application

Wed Mar 19, 2008 12:50pm EDT
 
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BOSTON, March 19 (Reuters) - Genzyme Corp (GENZ.O) said on Wednesday it has withdrawn a European application for permission to market its cancer drug Evoltra to elderly patients with acute myeloid leukemia.

The drug, which is known as Clolar in the United States, is currently approved to treat children with acute lymphoblastic leukemia who have relapsed or who have failed to respond to at least two prior treatment regimens.

Cambridge, Massachusetts-based Genzyme said it withdrew the application based on an assessment by European regulatory advisors that clinical trial data presented in the application is not strong enough to support approval.

The marketing application for the drug, also known as clofarabine, was submitted to European regulators by Bioenvision, a company that was acquired by Genzyme last year. (Reporting by Toni Clarke)

 
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