Thursday, April 17, 2014
FDA Approves Arzerra for CLL
The U.S. Food and Drug Administration has approved Arzerra (ofatumumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
Arzerra is a human monoclonal antibody that targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops. The drug had been granted breakthrough therapy designation last year (OT 10/10/13 issue).
The drug’s approval is based on results from a Phase III study of 447 patients with previously untreated CLL (and for whom fludarabine-based therapy was considered inappropriate by study investigators).
The data showed a statistically significant improvement in median progression-free survival in patients who received Arzerra and chlorambucil compared with patients who received chlorambucil alone (22.4 months versus 13.1 months, respectively).
The most common adverse events for patients receiving Arzerra were neutropenia, asthenia, headache, leukopenia, herpes simplex, lower respiratory tract infection, arthralgia, and upper abdominal pain. Infusion reactions were seen in 67 percent of patients receiving Arzerra, 10 percent being grade three or higher.
Arzerra is being developed under a co-development and collaboration agreement between Genmab and GlaxoSmithKline.