Novartis announced that Afinitor (everolimus tablets), an oral kinase inhibitor, has received accelerated approval for subependymal giant cell astrocytoma (SEGA), a benign brain tumor associated with tuberous sclerosis (TS), in patients who require therapeutic intervention but are not candidates for curative surgical resection. This approval was based on data from an open-label, single-arm, 28-patient study that evaluated the efficacy of Afinitor. The study showed that 32% of patients treated with Afinitor experienced a reduction of ≥50% in the size of largest SEGA at six months relative to baseline. The duration of response for these patients ranged from 3 months to 2.5 years (median 266 days).

is already indicated for the treatment of advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib.

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