FDA: Arzerra Approved for Chronic Lymphocytic Leukemia-- Scott Roberts
Tuesday, October 27, 2009
TUESDAY, Oct. 27 (HealthDay News) -- Arzerra (ofatumumab) has been approved by the U.S. Food and Drug Administration to treat chronic lymphocytic leukemia (CLL), a cancer of the blood and bone marrow.
The drug, produced by London-based GlaxoSmithKline, is approved when other types of chemotherapy no longer control the disease, the FDA said in a news release.
CLL, a slowly progressing form of leukemia, mostly affects people aged 50 and older. Some 16,000 people annually are diagnosed with the disease, and about 4,400 die, the agency said.
Arzerra binds to white blood cells known as B cells, making it easier for the body's immune system to fight cancerous B cells. The drug was approved under an accelerated process granted to drugs that satisfy unmet medical needs, the FDA said. Ongoing studies will establish whether combining Arzerra with standard forms of chemotherapy delays progression of CLL.
Common side effects recorded during clinical testing of Arzerra included an increased risk of progressive multifocal leukoencephalopathy (PML), an often-fatal brain infection. Also, people with a history of hepatitis should be carefully monitored while taking the drug.
Other side effects may include a decrease in blood cell counts, pneumonia, fever, cough, diarrhea, fatigue and shortness of breath, the FDA said.
The FDA has more about this drug's approval history.
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