Genmab A/S announced that the US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will hold a meeting on May 29, 2009 to review the Arzerra (ofatumumab) Biologics License Application (BLA) for the treatment of patients with chronic lymphocytic leukaemia (CLL) who have received prior therapy.

Genmab and GlaxoSmithKline submitted the BLA in January 2009 and announced that the FDA accepted it for review in April 2009. The FDA has granted ofatumumab priority review status.

Ofatumumab is a novel, investigational, fully human monoclonal antibody that targets a membrane-proximal (close to the cell surface) small loop epitope (a portion of a molecule to which an antibody binds) on the CD20 molecule of B-cells.