Neurologist

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Drug Information Update- FDA Approves New Treatment for Chronic Lymphocytic Leukemia

FDA/CDER/Division of Drug Information (DDI)

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.


 

The U.S. Food and Drug Administration today approved Arzerra (ofatumumab) for patients with chronic lymphocytic leukemia (CLL), a slowly progressing cancer of the blood and bone marrow.

Arzerra is approved for patients with CLL whose cancer is no longer being controlled by other forms of chemotherapy.

CLL primarily affects people older than 50 and arises from a group of white blood cells known as B-cells that are part of the body’s immune system. Each year, about 16,000 people are diagnosed with CLL and about 4,400 people die from the disease.

Arzerra is a monoclonal antibody, a type of biotechnology product. Antibodies that occur in nature are produced by the immune system in response to invaders. Arzerra binds to a specific protein found on the surface of both normal and malignant B cells, making the cells more susceptible to immune system attack.

For more information, please visit: Arzerra

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October 27, 2009 - Posted by | 1

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