Pharmaceutical firm Novartis has been given US Food and Drug Administration approval for Afinitor as a treatment of inoperable brain tumours.
The drug, also used to treat subependymal giant cell astrocytoma (SEGA), has been given accelerated approval based on an open-label, single-arm, 28-patient study conducted by Cincinnati Children’s Hopsital Medical Center in the US.
The medication had previously received approval for the treatment of renal cancer and in patients who had recently received cardiovascular stents.
A Phase III study is currently underway to determine Afinitor’s clinical benefits in the treatment of patients with SEGA associated with tuberous sclerosis in comparison to placebo.
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