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GlaxoSmithKline (GSK) And Genmab A/S (GEN.CO) Receive Priority Review From FDA For Arzerra® (Ofatumumab) As 1st Line Treatment For Chronic Lymphocytic Leukemia (CLL)


12/18/2013 8:04:01 AM

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Copenhagen, Denmark; December 17, 2013 – GlaxoSmithKline plc (LSE: GSK) and Genmab A/S (OMX: GEN) announced today that the US Food and Drug Administration (FDA) has granted Priority Review designation to the supplemental Biologics License Application (sBLA) 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 FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of April 19, 2014 for the sBLA for Arzerra®.

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