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Glaxosmithkline and genmab seek european marketing authorisation of arzerra (ofatumumab) in advanced stage blood cancer
Genmab, 02/06/09

GlaxoSmithKline (GSK) and Genmab A/S announced the submission of a Marketing Authorisation Application to the European Medicines Agency for Arzerra for the treatment of chronic lymphocytic leukaemia. If approved, ofatumumab would be indicated for the treatment of patients with CLL who have previously failed, or are inappropriate for, standard therapies. Ofatumumab targets a distinct binding site on the CD20 molecule of B-cells and it could become the first monoclonal antibody targeted to CD20 available for these patients. GSK and Genmab announced the submission of a Biologics License Application (BLA) to the US Food and Drug Administration on Friday, January 2009.

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