GSK/Genmab file Arzerra for CLL with EMA
Glaxo Smith Kline and Genmab have submitted a variation to the Marketing Authorisation to the European Medicines Agency 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 drug was approved in the EU in 2010.
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. Headline results from this trial were announced in May, 2013 and the full study results have been submitted for presentation at the 2013 American Society of Hematology Annual Meeting in December.
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