Ofatumumab: chronic lymphocytic leukaemia: a last resort

About 50% of patients with symptomatic chronic lymphocytic leukaemia in whom chlorambucil and fludarabine have failed die within 6 to 9 months. In addition to appropriate palliative care, alemtuzumab may offer patients a few extra months of life, but at a cost of several serious adverse effects. Ofatumumab, a monoclonal antibody similar to rituximab, has been authorised in the United States for the treatment of patients with chronic lymphocytic leukaemia refractory to fludarabine and alemtuzumab. The European Medicines Agency has issued a favourable opinion on marketing authorisation of ofatumumab in this setting. Clinical assessment of ofatumumab is based on an interim subgroup analysis of a non-comparative trial in 154 patients. Fludarabine and alemtuzumab therapy had failed in 59 patients. The median overall survival time in this subgroup of 59 patients was 13.7 months, and the time to progression was 5.7 months. Thirty-one of these 59 patients had non-specific symptoms of leukaemia, which disappeared for at least 2 and 6 months in respectively 48% and 23% of cases. The adverse effect profile of ofatumumab appears similar to that of rituximab, and includes hypersensitivity reactions, infections, cardiac disorders and neutropenia. In practice, despite the scarcity of data, the use of ofatumumab seems to be justified for patients who have no other valid therapeutic options, but more data are needed.