GlaxoSmithKline (GSK) and Danish biotechnology firm Genmab have filed a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for the use of its leukaemia drug Arzerra (ofatumumab) in combination with an alkylator-based therapy.
The combination drug is intended for treating chronic lymphocytic leukemia (CLL) patients who have not received prior treatment and are inappropriate for fludarabine-based therapy.
The submission is based on results secured from an international, multi-center, randomized Phase III study of ofatumumab in combination with chlorambucil versus chlorambucil alone in over 400 patients with previously untreated CLL.
The complete results of the trial will be presented at the 2013 American Society of Hematology Annual Meeting in December.
Ofatumumab, which is a human monoclonal antibody that targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops, is not licensed anywhere in the world for patients who have not received treatment for CLL.
Genmab and GSK are currently developing the drug as part of their co-development and collaboration agreement.