Arzerra™ Granted Accelerated Approved for Refractory Chronic Lymphocytic Leukemia
Arzerra™ (ofatumumab) has been granted accelerated approval by the U.S. Food and Drug Administration for treatment of patients with chronic lymphocytic leukemia (CLL) that is refractory to Fludara® (fludarabine) and Campath® (alemtuzumab).
Arzerra is a fully human monoclonal antibody that binds specifically to the small and large extracellular loops of the CD20 molecule proximal to the cell membrane. The CD20 molecule is a key target in B-cell malignancy therapy because it is expressed on most B-cells.
The approval of Arzerra was based on a study in which 42% of CLL patients refractory to Fludara and Campath responded to Arzerra. Median duration of response was 6.5 months. The most common serious adverse events were infections, neutropenia, and pyrexia.
Reference: Genmab and GSK press release. GSK and Genmab receive accelerated approval for ARZERRA™. Available at: http://www.gsk.com/media/pressreleases/2009/2009_us_pressrelease_10077.htm Accessed October 28, 2009.
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