Arzerra ofatumumab regulatory update

EMA's CHMP backed a label expansion for Arzerra ofatumumab from Genmab and partner GlaxoSmithKline to include first-line treatment of chronic lymphocytic leukemia (CLL) in combination with chlorambucil or bendamustine in patients considered inappropriate for fludarabine-based therapy. The partners said they expect a decision from the European Commission next quarter.

Last month, FDA approved an sBLA expanding Arzerra's U.S. label to include first-line CLL, for which the drug has breakthrough therapy designation from the agency. GSK already markets Arzerra in the U.S. and EU to treat CLL refractory to fludarabine and alemtuzumab. The pharma has worldwide co-development and commercialization rights to the human mAb against CD20 from Genmab. ...