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FDA approves TSC indication drug

The US FDA has approved Novartis Oncology's Afinitor for subependymal giant cell astrocytomas, a tuberous sclerosis complex indication

The US Food and Drug Administration (FDA) has approved Novartis Oncology's Afinitor (everolimus) for subependymal giant cell astrocytomas (SEGAs), a form of benign brain tumour associated with tuberous sclerosis.

SEGAs, which occur in 15-20 per cent of tuberous sclerosis complex (TSC) patients, are most common in paediatric and adolescent patients. TSC is estimated to affect more than one million patients worldwide. 

Afinitor is now approved by the FDA as a treatment for SEGAs in patients who are not eligible for surgical resection of the tumours. The approval was based on the results of an open-label study of patients receiving everolimus for a median of two years. After six months, of the 28 patients enrolled in the trial, 32 per cent experienced a reduction of 50 per cent or more in the size of their largest SEGA. No patients developed any new SEGAs for the duration of the treatment. 

Afinitor, which was already approved for the treatment of advanced renal cell carcinoma, is the first drug approved by the FDA specifically to treat SEGAs.

1st November 2010


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