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Arzerra sBLA for CLL Gets Priority Review status

GSK, Genmab biologic gets PDUFA date of April 19, 2014

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

GlaxoSmithKline and Genmab have received Priority Review designation from the FDA for the sBLA for the use of Arzerra (ofatumumab) in combination with an alkylator-based therapy, to be used for treatment of chronic lymphocytic leukemia (CLL) patients who have not received prior treatment and are inappropriate for fludarabine-based therapy. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of April 19, 2014 for the sBLA for Arzerra.

Ofatumumab is not approved or licensed anywhere in the world for use in patients who have not received treatment for CLL. CLL is the most common form of leukemia in adults. Based on estimates by the American Cancer Society, CLL will account for more than 15,680 new cases and more than 4,580 deaths in the U.S. in 2013.

Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops2. Ofatumumab has been granted Breakthrough Therapy Designation from the US FDA.

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