FDA OKs drug for tuberous sclerosis

The drug, Afinitor, is intended to treat slow-growing benign tumors TS causes to grow in the brain and in other parts of the body, including the eyes, lungs, liver, heart, skin and kidneys, an FDA release said Monday.

Such tumors, called subependymal giant cell astrocytomas, are considered a major diagnostic feature of TS, seen in 6 percent to 9 percent of patients. The disease can be fatal for patients who develop complications with tumor growth on the brain.

Surgery can be used to remove the tumor growths in some patients, but Afinitor has been approved for cases that cannot be treated with surgery, the FDA says.

"Patients with this disease currently have limited treatment options beyond surgical intervention," Dr. Richard Pazdur of the FDA's Center for Drug Evaluation and Research said. "It is important for research to continue in rare diseases where patients have few or no existing drug treatment options."

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