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On January 19, 2016, the U.S. Food and Drug Administration approved ofatumumab (Arzerra) for extended treatment of patients who are in complete or partial response following at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). Ofatumumab was previously approved for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy was considered inappropriate and also for patients with CLL refractory to fludarabine and alemtuzumab.
This new approval was based on close to doubling of progression-free survival (PFS) (29.4 months for ofatumumab versus 15.2 months with observation) in the randomized, open-label phase III PROLONG trial which compared ofatumumab to observation in patients whose disease had a complete or partial response after at least two lines of prior therapy. Additionally, the time to next therapy was 6.9 months longer with ofatumumab compared with observation.