Priority Review for Arzerra from GSK, Genmab

Genmab A/S (CSE:GEN; OTCBB:GMXAY) and partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said FDA accepted and granted Priority Review to an sBLA from GSK to expand the label of Arzerra ofatumumab to include first-line treatment of chronic lymphocytic leukemia (CLL). The PDUFA date is April 19. The application covers the use of Arzerra in combination with an alkylator-based therapy in treatment-naïve patients considered inappropriate for fludarabine-based therapy. In October, GSK submitted an application to EMA seeking to include the first-line indication on Arzerra's European label (see BioCentury Extra, Oct. 4). ...