Pediatric dosage approved for rare brain tumor

On Aug. 29, the FDA approved Afinitor Disperz (everolimus tablets for oral suspension), making it the first pediatric dosage approved for a pediatric tumor. While Afinitor has previously been available for patients 3 years or older, this new dosage form is to treat patients one year and older with tuberous sclerosis complex (TSC) who have a rare brain tumor, subependymal giant cell astrocytoma (SEGA), that can't be treated surgically. TSC is a genetic disorder that causes noncancerous tumors to form in various organs, and even though the tumors are noncancerous, they can still cause complications. SEGA tumors are generally slow-growing and form in 1 out of 10 individuals with TSC. SEGA is also more likely to affect children and young adults under 21. This dosage form is available in smaller amounts than the adult dosage and can dissolve in a small amount of water, making it easier to swallow. Side effects include mouth ulcers and respiratory tract infections. For more information on the approval visit the FDA site.For more information on TSC and SEGA, visit tsalliance.org.