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Genmab A/S and GlaxoSmithKline Submit sBLA for Arzerra (Ofatumumab) to US Regulatory Authorities

Friday, 18 Oct 2013 04:18pm EDT 

Genmab A/S and GlaxoSmithKline (GSK) announced that a supplemental Biologics License Application (sBLA) has been submitted to the US Food and Drug Administration (FDA) for the use of Arzerra (ofatumumab) in combination with an alkylator-based therapy, to be used for treatment of CLL 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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19 Dec 2014