EC approves Arzerra for first-line CLL

The European Commission approved a label expansion for Arzerra ofatumumab from Genmab A/S (CSE:GEN; OTCBB:GMXAY) and partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to include first-line treatment of chronic lymphocytic leukemia (CLL) in combination with chlorambucil or bendamustine in patients who have not received prior therapy or who are unsuitable for fludarabine-based therapy. Genmab said it expects GSK to launch the product for first-line treatment "in the coming months." GSK already markets Arzerra in the U.S. for first-line CLL and in the U.S. and EU for CLL refractory to fludarabine and alemtuzumab. The pharma has worldwide co-development and commercialization rights to the human mAb against CD20 from Genmab, which was off DKK1.92 to DKK228.60 on Thursday.

Novartis AG (NYSE:NVS; SIX:NOVN) is acquiring GSK's portfolio of marketed cancer drugs, which includes Arzerra, as part of a pair of multi-billion dollar deals that will see the pharmas sell assets to one another. The deals are slated to close in 1H15 (see BioCentury, April 28). ...