FDA approves chronic lymphocytic leukemia treatment

ROCKVILLE, Md. The Food and Drug Administration has approved a new treatment for a cancer that mostly affects the elderly.

The FDA announced the approval of GlaxoSmithKline’s Arzerra (ofatumumab) for the treatment of chronic lymphocytic leukemia, which mostly affects the immune system’s B-cells in people ages 50 years and older. About 16,000 people are diagnosed with CLL every year, and 4,400 die from it.

The drug, a monoclonal antibody, binds to a protein on the service of normal and cancerous B-cells, making them more vulnerable to attack by the immune system.

“The approval of Arzerra illustrates FDA’s commitment to using the accelerated approval process to approve drugs for patients who have limited therapeutic options,” said Richard Pazdur, director of the Office of Oncology Products in the FDA’s Center for Drug Evaluation and Research.