ARTICLE | Clinical News

Arzerra ofatumumab regulatory update

June 27, 2016 7:00 AM UTC

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. ...