Chronic Lymphocytic Leukemia

achieves higher surface density, efficiently activates in vitro complement-dependent cytotoxicity (CDC), and shows improved antibody-dependent cell-mediated phagocytosis (ADCC) even when the CD20 expression is low. The results of a pivotal study10 led to the approval of ofatumumab in October 2009 by the US Food and Drug Administration (FDA) for the treatment of CLL refractory to both fludarabine and alemtuzumab, and likewise, in April 2010, the European Medicines Agency (EMA) issued a conditional marketing authorization for the same indication although this required further clinical data in a dailylife setting. In this context, the European Research Initiative on CLL (ERIC) conducted a non-interventional, observational phase IV study to determine the safety and efficacy of ofatumumab in patients with pre-treated and poor prognosis CLL in daily practice, outside clinical trials.