GSK and Genmab file for Arzerra variation in Europe
UK pharma giant GlaxoSmithKline (LSE: GSK) and partner Denmark-based biotech firm Genmab (OMX: GEN) have submitted a variation to the Marketing Authorization to the European Medicines Agency for the use of Arzerra (ofatumumab) in combination with an alkylator-based therapy.
The application is for the drug to be used for treatment of chronic lymphocytic leukemia (CLL) patients who have not received prior treatment and are inappropriate for fludarabine-based therapy. It is already approved as a treatment for CLL itself.
The submission is based primarily on results from an international, multicenter, randomized 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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