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.
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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.
- 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.