Genzyme’s supplemental NDA for treating adult AML with Clolar to be discussed by the FDA

Aug 29 2009

Genzyme Corporation (Nasdaq: GENZ) announced today that its supplemental New Drug Application for Clolar^® (clofarabine) will be discussed Tuesday, September 1 at a public meeting of the FDA’s Oncologic Drugs Advisory Committee in Silver Spring, Maryland. The panel is expected to consider the clinical trial results Genzyme submitted to support the approval and labeling of Clolar to treat older adult patients with acute myeloid leukemia (AML), the most common type of acute leukemia in adults. Clolar is currently approved for pediatric acute lymphoblastic leukemia (ALL) patients who have relapsed or have refractory disease after at least two prior regimens.

Genzyme’s supplemental NDA seeks approval for Clolar’s use as a single agent in previously untreated adults aged 60 or older with AML who have at least one unfavorable prognostic risk factor. Many older AML patients with unfavorable prognostic factors currently have poor treatment outcomes using currently available therapies for initial induction therapy. Clinical studies to optimize therapeutic approaches with existing agents have not resulted in improved outcomes in older adults with AML during the last three decades. The last induction therapy for newly diagnosed AML patients was approved in 1990. If approved, Clolar would fulfill an unmet need for this difficult to treat patient population.