GSK's leukemia drug Arzerra wins FDA approval for expanded use

04/18/2014 | Medscape (free registration)

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.

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