The FDA approved a new pediatric dosage form of everolimus (Afinitor Disperz) to treat the rare brain tumor called subependymal giant cell astrocytoma (SEGA). This is the first approved pediatric-specific dosage form developed for the treatment of a pediatric tumor.
Afinitor Disperz is recommended to treat patients aged 1 year and older with tuberous sclerosis complex who are diagnosed with SEGA that cannot be treated with surgery. Prior to approval of this new dosage form, everolimus was recommended for use only in patients aged 3 years and older. The drug was granted accelerated approval in 2010 to treat SEGA in patients with tuberous sclerosis complex. ■