BioCentury
ARTICLE | Top Story

Arzerra gets breakthrough designation for first-line CLL

September 13, 2013 11:21 PM UTC

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and partner Genmab A/S (CSE:GEN) said FDA granted breakthrough therapy designation to Arzerra ofatumumab for first-line treatment of chronic lymphocytic leukemia (CLL). The designation covers the use of Arzerra to treat previously untreated CLL in combination with chlorambucil chemotherapy in patients considered inappropriate for fludarabine-based therapy. In May, the partners said Arzerra plus chlorambucil met the primary endpoint of improving median progression-free survival (PFS) vs. chlorambucil alone in the Phase III COMPLEMENT-1 trial for first-line CLL (22.4 vs. 13.1 months, p<0.001) (see BioCentury, June 10). ...