The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for ofatumumab (Arzerra) in combination with chlorambucil (Leukeran) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have not received prior treatment and are inappropriate for fludarabine-based therapy.
Ofatumumab, a human monoclonal antibody that targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops, is not approved or licensed anywhere in the world for use in this treatment setting. Breakthrough Therapy Designation is the newest of the FDA’s programs aimed at accelerating the development and review times of drugs for serious or life-threatening conditions.
The Breakthrough Therapy designation was based on the results from an international, multicenter, randomized phase III clinical trial in more than 400 patients with previously untreated CLL. The full study results have been submitted for presentation at the 2013 American Society of Hematology Annual Meeting in December.
Ofatumumab is being developed under a codevelopment and commercialization agreement between Genmab and GlaxoSmithKline. ■