US Drug Reviewers Question Genzyme Study For Clolar

US drug reviewers have questioned a Genzyme study meant to back wider use of the Clolar leukemia drug.

Clolar is approved for treating a type of leukemia in children. Genzyme is seeking permission to promote the drug more widely to adults with acute myeloid leukemia (AML).

Genzyme said, current treatments for adults with AML are insufficient and the company’s ‘data demonstrate clinically meaningful benefits and manageable risks’ for adults age 60 or older with at least one unfavorable risk factor.

Reportedly, the FDA will consider the advisory panel’s input before deciding whether to approve Clolar for adult use.

A staff of FDA, said: ‘The lack of a randomized study combined with the heterogeneous patient population regarding AML prognostic factors makes interpretation of the study results difficult.’