GlaxoSmithKline (GSK) and Genmab have submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) seeking the use of Arzerra (ofatumumab) in combination with an alkylator-based therapy in patients with chronic lymphocytic leukaemia (CLL) who have not received prior treatment.

The sBLA is based on results secured from an international, multi-centre, randomised Phase III trial of ofatumumab in combination with chlorambucil versus chlorambucil alone in more than 400 patients with previously untreated CLL.

Full results of the Phase III trial will be presented at the 2013 American Society of Hematology Annual Meeting in December.

Ofatumumab is a human monoclonal antibody that targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops. It is not licensed anywhere in the world for use in patients who have not received treatment for CLL, the most common form of leukaemia in adults.

The drug is currently being developed under a co-development and collaboration deal between Genmab and GSK.

The sBLA follows the recent submission of Arzerra by both the companies to the European Medicines Agency (EMA) for a variation in marketing authorisation.

Genmab is involved in the development and manufacturing of differentiated human antibody therapeutics for the treatment of cancer.

The company's first marketed antibody, ofatumumab, was approved for the treatment of CCL patients who are refractory to fludarabine and alemtuzumab after less than eight years in development.