GSK and Genmab Receive Priority Review from FDA for Arzerra® (ofatumumab) as 1st Line Treatment for Chronic Lymphocytic Leukaemia (CLL)

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.
Source: GSK news - Category: Pharmaceuticals Source Type: news