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FDA Approves Maintenance Ofatumumab in CLL

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.

In the open-label study, maintenance ofatumumab demonstrated a median PFS of 29.4 versus 15.2 months with observation, representing a 50% reduction in the risk of progression (HR, 0.50; 94% CI, 0.38-0.66; P <.0001). Additionally, the time to next therapy was 6.9 months longer with ofatumumab compared with observation.

In the PROLONG trial, 474 patients who experienced a partial or complete response with either second- or third-line therapy were randomized to ofatumumab (n = 238) or observation (n = 236). In the first cycle, ofatumumab was administered at an initial dose of 300 mg followed 1 week later by a 1000-mg dose. For subsequent cycles, the 1000-mg dose was administered every 8 weeks for up to 2 years. Click here to read the full article at

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