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news.GlaxoSmithKline (GSK) and Genmab have reported that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for conditional approval of Arzerra (ofatumumab) in Europe, for refractory chronic lymphocytic leukaemia (CLL).
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Ofatumumab is a human monoclonal antibody with a mode of action. It targets a part of CD20 molecule encompassing an epitope in the small loop (Teeling et al 2006). The CD20 molecule is a key target in CLL therapy as it is expressed in most B cell malignancies (Cragg et al 2005).
The CHMP has recommended the conditional marketing authorisation of ofatumumab in the EU for the treatment of patients with CLL, who are refractory to fludarabine and alemtuzumab. Fludarabine and alemtuzumab are standard therapies currently used to treat CLL (Abbott 2006/Robak 2008).
Reportedly, as part of the conditions of the conditional marketing authorisation for ofatumumab, GSK will be required to provide further data.
In patients with CLL, who have not responded to treatment or who have disease progression within six months to the latest treatment, the disease is termed refractory.