Afinitor Disperz Approved for Rare Tumor
Sanctioned for children aged 1 and older
WEDNESDAY, Aug. 29, 2012 (HealthDay News) -- The U.S. Food and Drug Administration has approved Afinitor Disperz (everolimus tablets for oral suspension), the first form of the drug Afinitor to be created especially for children.
The drug was approved for children aged 1 and older who have tuberous sclerosis complex (TSC) and an accompanying rare but benign brain tumor, subependymal giant cell astrocytoma (SEGA), that cannot be treated with surgery.
TSC is a rare genetic disease that often spurs benign tumors in the brain and other key organs, the FDA said in a news release.
Afinitor Disperz is available in smaller doses than its adult counterpart. It also is meant to dissolve in a small amount of water, making it easier to give to children who can't swallow tablets, the agency said.
The most common side effects observed during clinical testing were mouth ulcers and respiratory infections.
Afinitor has received a number of prior approvals for adults. Both versions of the drug are produced by Novartis, based in East Hanover, N.J.
The FDA has more about this approval.