FDA approves Afinitor Disperz (Novartis) for SEGA Tumours

The FDA has on 29 August 2012 approved Afinitor Disperz (everolimus tablets for oral suspension; Novartis), a new pediatric dosage form of Afinitor (everolimus) indicated for treatment of Tuberous Sclerosis Complex (TSC) in patients aged >1 year who are diagnosed with Subependymal Giant Cell Astrocytoma (SEGA) that cannot be treated with surgery. Afinitor Disperz is the first approved pediatric-specific dosage form developed for the treatment of a pediatric tumor. Prior to approval of this new dosage form, Afinitor was recommended for use only in patients aged >3 years. In 2010, Afinitor was granted accelerated approval to treat SEGA in patients with TSC. Afinitor Disperz dissolves easily in a small volume of water and is available in smaller dose increments than the adult dosage form.