FDA extends Arzerra's review period for chronic lymphocytic leukaemia
This article was originally published in Scrip
Executive Summary
The US FDA has extended by three months the review period for GlaxoSmithKline/Genmab's anti-CD20 monoclonal antibody drug Arzerra (ofatumumab), which the companies filed in January for its first indication, chronic lymphocytic leukaemia (CLL).