European Commission grants accelerated approval to Arzerra
Brussels – The European Commission has granted conditional market approval to GlaxoSmithKline’s human anti-CD20 monoclonal antibody Arzerra (ofatumumab) for patients with chronic lymphocytic leukemia (CLL), a slowly progressing cancer of the blood and bone marrow. Arzerra is approved for patients with CLL whose cancer is no longer being controlled by standard therapy with fludarabine and alemtuzumab. GSK’s developement partner, Genmab A/S, which received a EUR 12 million milestone payment,announced that full approval will be dependent on submission of additional clinical data from a Phase IV trial. The drug received the green light last October from the US food and Drug Administration for this indication.