- In a 447-patient study published in The Lancet, Novartis' (NVS -0.5%) Arzerra (ofatumumab) plus the chemotherapeutic agent chlorambucil demonstrated a statistically significant improvement in progression-free survival (PFS) compared to chlorambucil alone in previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy was considered inappropriate (due to advanced age or the presence of comorbidities). CLL is the most common form of leukemia, accounting for 25% of leukemia cases.
- Median PFS improved 71% in the ofatumumab/chlorambucil cohort versus chlorambucil alone (22.4 months vs. 13.1 months; p<0.0001).
- The FDA approved Arzerra in April 2014 followed by European Commission clearance in July.