GlaxoSmithKline plc and Genmab A/S have submitted a variation to the marketing authorisation application (MAA) to the European Medicines Agency (EMA) for the use of Arzerra (ofatumumab) in combination with an alkylator-based therapy, to be used for treatment of Chronic Lymphocytic Leukaemia (CLL) patients who have not received prior treatment and are inappropriate for fludarabine-based therapy.
The submission is based primarily on results from an international, multi-centre, randomised phase III study of ofatumumab in combination with chlorambucil versus chlorambucil alone in more than 400 patients with previously untreated CLL.
The results from this trial were reported in May, 2013 and the full study results have been submitted at the 2013 American Society of Hematology Annual Meeting in December.
Arzerra (ofatumumab) is not approved or licensed anywhere in the world for use in patients who have not received treatment for CLL. Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops. Ofatumumab is being developed under a co-development and commercialisation agreement between Genmab and GlaxoSmithKline.
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer.
GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.