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Afinitor Approved for Rare Genetic Disorder

Afinitor Approved for Rare Genetic Disorder

11/01/10

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 fever.

Afinitor is marketed by Novartis, based in East Hanover, N.J.

More information

To learn more about this approval, visit the FDA.

Copyright © 2010 HealthDay. All rights reserved.

Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.

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