The FDA has approved a new indication for Arzerra (ofatumumab; GlaxoSmithKline) to use in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL), for whom fludarabine-based therapy is considered inappropriate.

The approval is based on a multi-center, randomized, open-label trial of comparing ofatumumab in combination with chlorambucil to single agent chlorambucil. The trial enrolled 447 patients with CLL and for whom fludarabine-based therapy was not appropriate due to advanced age or presence of co-morbidities. Patients received pre-medication with acetaminophen, an antihistamine, and a glucocorticoid prior to the ofatumumab infusion.

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The trial met the primary endpoint of progression free survival (PFS), with a median PFS of 22.4 months (95% CI: 19.0, 25.2 months) for patients receiving Arzerra in combination with chlorambucil, compared to 13.1 months (95% CI: 10.6, 13.8 months) for patients receiving chlorambucil [hazard ratio 0.57 (95% CI: 0.45, 0.72), stratified log-rank P-value <0.001].

Arzerra, a CD20-directed cytolytic monoclonal antibody, is already approved for chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab.

Arzerra is available as 100mg/5mL and 1000mg/50mL strengths in single-use vials.

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This article originally appeared on MPR