FDA Approves Ofatumumab for Recurrent or Progressive Chronic Leukemia

The U.S. Food and Drug Administration (FDA) has approved ofatumumab (Arzerra) for extended treatment of patients who are in complete or partial response after at least 2 lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL).¹

This indication is based on findings from an open-label trial that compared ofatumumab with observation in 474 patients who achieved a complete or partial response after at least 2 lines of prior therapy.

Results of that study showed that investigator-assessed median progression-free survival was 29.4 months (95% CI, 26.2 – 34.2) with ofatumumab vs 15.2 months (95% CI, 11.8 – 18.8) with observation (HR, 0.50; 95% CI,  0.38 – 0.66; P < .0001).

The most common adverse events in patients treated with immunotherapy were infusion reactions, neutropenia, and upper respiratory tract infection. A total of 33% of patients treated with ofatumumab experienced serious adverse events, the most frequent of which were pneumonia, pyrexia, and neutropenia, including febrile neutropenia.

The recommended dose and schedule of ofatumumab therapy is 300 mg administered intravenously on day 1, followed by 1000 mg given on day 8 and a dose 7 weeks later, and then every 8 weeks thereafter for a maximum of 2 years of therapy.

Ofatumumab is already approved for the treatment of previously untreated patients with CLL who are not eligible to receive fludarabine-based therapy and for patients with CLL refractory to fludarabine and alemtuzumab.

Reference

1. Ofatumumab (Arzerra Injection). U.S. Food and Drug Administration website. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm482308.htm. Published January 19, 2016. Accessed January 19, 2016.