[COLOR="#000000"]GlaxoSmithKline plc and Genmab A/S have announced the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for the use of Arzerra® (ofatumumab) in combination with an alkylator-based therapy, to be used for treatment of CLL patients who have not received prior treatment and are inappropriate for fludarabine-based therapy.
The application 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. Headline results from this trial were announced in May, 2013 and the full study results are scheduled to be presented at the 2013 American Society of Hematology Annual Meeting in December.
About Chronic Lymphocytic Leukaemia
CLL is the most common form of leukaemia in adults. Based on estimates by the American Cancer Society, CLL will account for more than 15,680 new cases and more than 4,580 deaths in the United States of America alone in 2013. At present, no curative chemotherapy is available.
About Arzerra® (ofatumumab)
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 loops2. Ofatumumab is being developed under a co-development and collaboration agreement between Genmab and GlaxoSmithKline.[/color]