FDA Approves Arzerra for Extended Treatment of CLL

The FDA today approved a new extended treatment option for patients with leukemia.

Ofatumumab (Arzerra) was granted approval for the extended treatment of patients with recurrent or progressive chronic lymphocytic leukemia (CLL) who are in complete or partial response following at least 2 lines of therapy.

Arzerra was found to offer a significant gain in progression-free survival (PFS) compared with observation in the phase 3 PROLONG trial.

Arzerra was previously approved for CLL patients who have not been treated and could not take fludarabine-based therapy.

During a clinical trial, researchers evaluated 474 patients between the ages of 33 and 87 with a median age of 64.5 years, randomized (1:1) to Arzerra (n+238) or observation (n=236). Patients in the Arzerra group received a median of 2 prior therapies.

The median PFS was 29.4 months (95% CI: 26.2, 34.2) in the Arzerra group versus 15.2 months (95% CI: 11.8, 18.8) in the observation [HR: 0.50 (95% CI: 0.38, 0.66), p-value < 0.0001] group.

For patients on Arzerra therapy, the first day dose should be 300-mg by intravenous infusion and then 1000-mg on day 8 and 7 weeks later, and every 8 weeks for a maximum of 2 years.

The most common adverse reactions to Arzerra were infusion reactions, neutropenia, and upper respiratory tract infection.

Approximately 33% of patients had severe adverse reactions, including pneumonia, pyrexia, and neutropenia.