GSK/Genmab gain expanded US approval for Arzerra
This article was originally published in Scrip
Executive Summary
The FDA gave the go-ahead on 17 April for GlaxoSmithKline and Genmab to market Arzerra (ofatumumab), a CD20-directed monoclonal antibody, as a therapy in combination with chlorambucil for use in previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate, expanding the drug's indication.