GlaxoSmithKline and Genmab A/S have announced the submission of leukaemia drug Arzerra to the European Medicines Agency (EMA) for a variation in marketing authorisation.
The companies are seeking authorisation for the drug to be used in combination with an alkylator-based therapy for treatment of Chronic Lymphocytic Leukemia (CLL) patients who have not received prior treatment and are inappropriate for fludarabine-based therapy.
The submission is off the back of 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 full study results have been submitted for presentation at the 2013 American Society of Hematology Annual Meeting in December.
Ofatumumab is a human monoclonal antibody, which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops 2.
It is not currently licensed anywhere in the world for use in patients who have not received treatment for CLL.
CLL is the most common form of leukemia in adults. In Europe, the incidence rate is 4.92 per 100,000, or approximately 11,019 new cases each year. At present, no curative chemotherapy is available.
Image: GSK’s headquarters in the UK. Photo: courtesy of Maxilwell Hamilton.
