FDA Approves New Option for Patients with Relapsed CLL
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.