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FDA Approves Maintenance Ofatumumab in CLL

Jason M. Broderick @jasoncology
Published: Tuesday, Jan 19, 2016

The FDA has approved ofatumumab (Arzerra) for the extended treatment of patients with recurrent or progressive chronic lymphocytic leukemia (CLL) who are in complete or partial response following at least two lines of therapy, based on a near doubling in progression-free survival (PFS) seen with the treatment compared with observation in the phase III PROLONG trial.

van Oers MHJ, Kuliczkowski K, Smolej L, et al. Ofatumumab maintenance versus observation in relapsed chronic lymphocytic leukaemia (PROLONG): an open-label, multicentre, randomised phase 3 study [published online ahead of print September 13, 2015]. Lancet Oncol.

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