The Food and Drug Administration (FDA) has approved Arzerra (ofatumumab) Novartis) Injection for extended treatment of patients with complete or partial response after ≥2 lines of therapy, for recurrent or progressive chronic lymphocytic leukemia (CLL). The FDA had granted this application Priority Review.
The approval was based on data from a randomized, open-label trial (n=474) that showed an improvement in progression-free survival (PFS) with Arzerra vs. observation in patients whose disease had a complete or partial response after ≥2 lines of therapy. Investigator-assessed median PFS was 29.4 months (95% CI: 26.2, 34.2) vs.15.2 months (95% CI: 11.8, 18.8) in the Arzerra vs. observation arms, respectively (HR: 0.50, 95% CI: 0.38, 0.66; P<0.0001).
The most common adverse reactions (≥10%) were infusion reactions, neutropenia, and upper respiratory tract infection. The two most common grade 3-4 adverse events were neutropenia (22% in ofatumumab arm vs 8% in observation arm), and pneumonia (5% in ofatumumab arm vs 3% in observation arm).
Arzerra Injection is already indicated 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.
Arzerra is a CD20-directed cytolytic monoclonal antibody that binds specifically to both the small and large extracellular loops of the CD20 molecule. Data suggest that possible mechanisms of cell lysis include complement-dependent cytotoxicity and antibody-dependent, cell-mediated cytotoxicity
Arzerra Injection is available as 100mg/5mL single-use vials in 3-count cartons, and as a 1000mg/50mL single-use vials in 1-count cartons.
For more information visit FDA.gov.