Posted on Tue, Oct. 27, 2009
NEW YORK - GlaxoSmithKline PLC received FDA approval for its drug Arzerra as a treatment for chronic lymphocytic leukemia, a slowly progressing cancer of the blood and bone marrow.
The FDA said in a statement yesterday that the approval applies to patients who have already received other forms of chemotherapy, which are no longer effective at controlling the condition.
Arzerra, a monoclonal antibody, 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.
Chronic lymphocytic leukemia 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 the disease and about 4,400 people die from it.
The FDA approved Arzerra under its accelerated approval process, which aims to speed drugs to market for patients with limited treatment options.
As part of that process, GlaxoSmithKline is conducting a clinical trial in chronic lymphocytic leukemia patients to confirm that the addition of Arzerra to standard chemotherapy delays the progression of the disease.
The most serious side effect of the drug is a potentially fatal brain infection called progressive multifocal leukoencephalopathy.
GlaxoSmithKline has major operations in Philadelphia.
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