BioCentury
ARTICLE | Company News

GSK, Genmab seek expansion of EU label for Arzerra

October 5, 2013 12:17 AM UTC

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and partner Genmab A/S (CSE:GEN; OTCBB:GMXAY) said GSK submitted an application to EMA seeking to expand the label for Arzerra ofatumumab to include first-line treatment of chronic lymphocytic leukemia (CLL). The application covers the use of Arzerra in combination with an alkylator-based therapy in patients considered inappropriate for fludarabine-based therapy. In May, the partners said Arzerra plus chlorambucil chemotherapy met the primary endpoint of improving median progression-free survival (PFS) vs. chlorambucil alone in the Phase III COMPLEMENT-1 trial for first-line CLL (see BioCentury, June 10). ...