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FDA approves Arzerra for extended treatment of CLL
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The FDA today approved ofatumumab for the extended treatment of patients with recurrent or progressive chronic lymphocytic leukemia who are in complete or partial response after at least two lines of therapy.
The FDA based its decision in part on results of a study composed of 474 patients (median age, 64.5 years; range, 33-87) with CLL whose disease had complete or partial response after second- or third-line therapy.
Researchers randomly assigned patients to receive ofatumumab (Arzerra, Novartis; n = 238) or undergo observation (n = 236). Patients in the ofatumumab arm had received a median of two (range, 2-5) prior therapies.
Patients who received ofatumumab demonstrated a median PFS of 29.4 months, whereas patients who underwent observation demonstrated a median PFS of 15.2 months in (HR = 0.5; 95% CI, 0.38-0.66).
Common adverse events in the ofatumumab arm included infusion reactions, neutropenia and upper respiratory tract infection.
Thirty-three percent of patients treated with ofatumumab experienced serious adverse reactions. The most common serious adverse reactions included pneumonia, pyrexia and neutropenia.
The FDA previously approved ofatumumab for the treatment of treatment-naive patients with CLL for whom fludarabine-based therapy was considered inappropriate, as well as for patients with CLL refractory to fludarabine and alemtuzumab.