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GSK, Genmab Submit sBLA for Arzerra in CLL

Covers combination alkylator-based therapy for CLL

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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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