BioCentury
ARTICLE | Company News

GSK, Genmab seek to extend U.S. label for Arzerra

October 19, 2013 12:29 AM UTC

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and partner Genmab A/S (CSE:GEN; OTCBB:GMXAY) said GSK submitted an sBLA to FDA 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 treatment-naïve patients considered inappropriate for fludarabine-based therapy. Earlier this month, GSK submitted an application to EMA seeking to include the first-line indication on Arzerra's European label (see BioCentury Extra, Oct. 4). ...