FDA approves Arzerra

FDA granted accelerated approval to a BLA for Arzerra ofatumumab from Genmab A/S (CSE:GEN) and GlaxoSmithKline plc (LSE:GSK;NYSE:GSK) to treat chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab. The approval triggers a DKK116 million ($23.4 million) milestone payment to Genmab from GSK, which has exclusive, worldwide rights from the biotech to co-develop and commercialize the mAb against CD20. In May, FDA's Oncologic Drugs Advisory Committee voted 10-3 in favor of approving the drug (See BioCentury, June 01, 2009). ...