GSK Ahead of Genentech to File BLA for CLL Drug

GlaxoSmithKline (GSK) and Genmab have submitted a BLA for their investigational anti-CD20 antibody Arzerra to treat chronic lymphocytic leukemia (CLL) at least five months before Genentech plans to file an application for Rituxan to treat CLL. GSK wants to market Arzerra (ofatumumab) to treat CLL in patients who don’t benefit from Genzyme’s Campath (alemtuzumab) and Bayer HealthCare’s anti-CD52 antibody and chemotherapy drug fludarabine. If approved, Arzerra would be the first anti-CD20 monoclonal antibody for that population, GSK and Genmab say in a statement.
Washington Drug Letter