If approved, Arzerra (ofatumumab) would be indicated for the treatment of patients with chronic lymphocytic leukemia who have previously failed, or are inappropriate for, standard therapies. The marketing authorization application (MAA) was submitted on February 5, 2009.
The acceptance of the MAA will trigger a milestone payment from GlaxoSmithKline to Genmab of approximately $10 million.
Lisa Drakeman, CEO of Genmab, said: “We are excited to reach this important milestone so soon after submitting the Arzerra MAA to the European regulatory authorities.”