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FDA approves Arzerra for first-line CLL

April 18, 2014 12:53 AM UTC

FDA approved an sBLA from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) expanding the label for Arzerra ofatumumab to include first-line treatment of chronic lymphocytic leukemia (CLL). The new indication covers the use of Arzerra in combination with chlorambucil when fludarabine-based therapy is inappropriate. An application to add the first-line indication to Arzerra's European label is still under review. The pharma already markets the human mAb against CD20 in the U.S. and EU to treat CLL refractory to fludarabine and alemtuzumab.

GSK has worldwide co-development and commercialization rights to Arzerra from partner Genmab A/S (CSE:GEN; OTCBB:GMXAY). The Nordic markets were closed on Thursday. ...