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Arzerra (Ofatumumab) Receives Positive Opinion for Conditional Approval in Europe for Refractory Chronic Lymphocytic Leukaemia

26 Jan 2010 - GlaxoSmithKline and Genmab A/S announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Arzerra(TM) (ofatumumab), for the treatment of refractory chronic lymphocytic leukaemia (CLL).
 
The CHMP has recommended the conditional marketing authorisation of ofatumumab in the European Union 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).