Afinitor Approved for Rare Genetic Disorder11/01/10
MONDAY, Nov. 1 (HealthDay News) -- Afinitor (everolimus) has
received expanded approval from the U.S. Food and Drug
Administration to treat subependymal giant cell astrocytoma (SEGA)
associated with tuberous sclerosis, a rare genetic disorder.
The disorder causes non-cancerous tumors on the brain and other
parts of the body, including the eyes, lungs, liver, heart, skin
and kidneys. It can be fatal if the brain tumors lead to
complications, the FDA said in a news release. Symptoms may include
learning disabilities, seizures, and lung and kidney disease.
Afinitor was first approved in March 2009 to treat kidney cancer
among people in whom standard therapies had failed.
In clinical studies of people with this disorder, the most
common side effects of Afinitor included infections of the upper
respiratory tract, sinuses and ears, as well as mouth sores and
Afinitor is marketed by Novartis, based in East Hanover,
To learn more about this approval, visit the
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