Regulatory update – GSK and Genmab announce European submission to regulatory authorities for Arzerra® (ofatumumab) as 1st line treatment of Chronic Lymphocytic Leukaemia (CLL)

GlaxoSmithKline plc and Genmab A/S [OMX: GEN] announced today the submission of a variation to the Marketing Authorisation to the European Medicines Agency (EMA) 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