FDA approves Afinitor to treat brain tumours

The US Food and Drug Administration (FDA) has approved Novartis’ Afinitor (everolimus) tablets to treat adults and children with benign brain tumours associated with tuberous sclerosis.

The US Food and Drug Administration (FDA) has approved Novartis’ Afinitor (everolimus) tablets to treat adults and children with benign brain tumours associated with tuberous sclerosis (TS), a genetic disorder that may cause tumours to form in vital organs. Prior to the approval of Afinitor, Novartis says brain surgery was the only treatment option for patients with growing Subependymal giant cell astrocytoma (SEGA) tumours. The approval is based on a 28-patient study conducted by Cincinnati Children''s Hospital Medical Center in the US, which showed that nearly one-third of patients (32%) experienced a reduction of 50% or greater in the size of their largest SEGA tumours after six months. A Phase III study is underway that compares Afinitor to placebo to explore its clinical benefits for the treatment of patients with SEGA associated with TS. Tuberous sclerosis is a genetic disorder affecting approximately 25,000–40,000 people in the US. SEGAs occur in up to 20% of patients wit