GlaxoSmithKline and Genmab have submitted a sBLA to the FDA for the use of Arzerra (ofatumumab) in combination with an alkylator-based therapy, for the treatment of Chronic Lymphocytic Leukemia (CLL) in patients who have not received prior treatment and are inappropriate for fludarabine-based therapy.   The application is based on results from an international, multi-center, randomized Phase III study of Arzerra in combination with chlorambucil versus chlorambucil alone in more than 400 patients...