New treatment option for CLL
A new treatment option, of ofatumumab (Arzerra) in combination with an alkylator-based therapy, has been approved in the U.S. for patients with chronic lymphocytic leukaemia (CLL).
The treatment is intended for patients with untreated CLL and who cannot receive fludarbine-based chemotherapy. Ofatumumab received a Breakthrough Designation from the Food and Drug Administration. Its approval is based on results from an international, multicentre, randomised phase III clinical trial in more than 400 patients with untreated CLL.
The goal of the Breakthrough Designation is to accelerate the development and review of drugs that treat serious or life-threatening illnesses when preliminary clinical evidence shows that the treatment may demonstrate substantial improvement on at least one clinically significant end point over other available treatments.
Ofatumumab, a human monoclonal antibody, targets an epitope on the CD20 molecule that encompasses parts of the small and large extracellular loops.