GSK/Genmab win FDA's 'breakthrough' status for Arzerra in CLL
This article was originally published in Scrip
Executive Summary
GlaxoSmithKline and Genmab gained the US FDA's breakthrough therapy designation for Arzerra (ofatumumab) in combination with chlorambucil as a treatment for patients with chronic lymphocytic leukemia (CLL) who have not received prior treatment and are inappropriate for fludarabine-based therapy.