The FDA has approved Arzerra (ofatumumab, from GlaxoSmithKline and Genmab), a monoclonal antibody, for the treatment of chronic lymphocytic leukemia (CLL) that is refractory to fludarabine (Fludara, from Genzyme) and alemtuzumab (Campath, from Genzyme). Arzerra was approved under the FDA’s accelerated approval process based on results from a pivotal study in which 42% of patients with CLL who were refractory to both fludarabine and alemtuzumab responded to treatment with Arzerra. A median duration of response of 6.5 months was observed. GlaxoSmithKline is currently conducting a clinical trial in CLL patients to confirm that the addition of Arzerra to standard chemotherapy delays the progression of the disease.

Arzerra is expected to be available in mid-November 2009.

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