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Covers combination alkylator-based therapy for CLL
October 21, 2013
By: Tim Wright
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 with previously untreated CLL.
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