Arzerra ofatumumab regulatory update

EMA’s CHMP recommended against expanding the label of Arzerra ofatumumab from Novartis to include maintenance treatment of relapsed chronic lymphocytic leukemia (CLL). CHMP said findings on progression-free survival (PFS) with the use of Arzerra “were not supported by other measures such as overall survival or a significant improvement in patients’ quality of life.” The agency concluded the benefits of the human mAb against CD20 did not outweigh its risks. ...