GlaxoSmithKline obtained the FDA's full approval to market Arzerra injection, or ofatumumab, in combination with chlorambucil, for patients with previously untreated chronic lymphocytic leukemia who can't take fludarabine-based drugs. The approval was based on data from a multicenter trial that showed improvements in progression-free survival among patients who took the combination therapy. Arzerra is already cleared for treatment of CLL patients who don't respond to alemtuzumab and fludarabine.

Related Summaries