FDA grants GSK and Genmab’s Arzerra® (ofatumumab) Breakthrough Therapy designation for previously untreated chronic lymphocytic leukaemia

GlaxoSmithKline plc (LSE:GSK) and Genmab A/S (OMX: GEN) announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Arzerra® (ofatumumab) in combination with chlorambucil for the treatment of patients with chronic lymphocytic leukaemia (CLL) who have not received prior treatment and are inappropriate for fludarabine-based therapy.
Source: GSK news - Category: Pharmaceuticals Source Type: news