Ofatumumab (Arzerra) approved for recurrent or progressive chronic lymphocytic leukemia (CLL)

January 20, 2016 – The American Food and Drug Administration (FDA) just approved Ofatumumab (Arzerra)  Injection for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). Ofatumumab, also known as HuMax-CD20, is a fully human monoclonal antibody directed against the CD20 protein which appears to inhibit early-stage B lymphocyte activation. Ofatumumab (Arzerra) 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 (Campath).

This new approval was based on demonstration of an improvement in progression-free survival (PFS) in a randomized, open-label trial comparing Ofatumumab (Arzerra) to observation in patients whose disease had a complete or partial response after at least two lines of prior therapy. A total of 474 patients were randomized (1:1) to Ofatumumab (Arzerra) (n=238) or observation (n=236). The median age was 64.5 years (range 33-87).  Patients in the Ofatumumab (Arzerra) arm had received a median of 2 prior therapies (range 2-5).  The investigator-assessed median PFS was 29.4 months (95% CI: 26.2, 34.2) and 15.2 months (95% CI: 11.8, 18.8) in the Ofatumumab (Arzerra) and observation arms, respectively [HR: 0.50 (95% CI: 0.38, 0.66), p-value < 0.0001].