GlaxoSmithKline plc and Denmark-based biotechnology company Genmab A/S announced that the European Commission or EC has granted marketing authorization for a new indication for the use of Arzerra or ofatumumab, a human monoclonal antibody against CD20, in combination with chlorambucil or bendamustine for the treatment of patients with chronic lymphocytic leukemia or CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy.
The approval is based on Phase III data from study with ofatumumab + chlorambucil & Phase II data from study with ofatumumab and bendamustine.
For more details, go to: http://www.rttnews.com/2345280/gsk-genmab-get-ec-marketing-authorization-for-new-indication-for-use-of-arzerra.aspx