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Novartis’ Afinitor (everolimus) tablets have been approved by the US Food and Drug Administration (FDA) for treating adult patients with renal angiomyolipomas and tuberous sclerosis complex (TSC), who do not require immediate surgery.

Afinitor reduces cell proliferation and blood vessel growth by inhibiting mTOR, a protein implicated in many tumour-causing pathways.

The approval is based on the Phase III EXamining everolimus In a Study of TSC (EXIST-2) trial, which showed that 42% of patients on Everolimus experienced an angiomyolipoma response versus 0% of patients in the placebo arm.

EXIST-2 is a double-blind placebo-controlled international multicentre Phase III study in which trial patients were randomised 2:1 to receive either Everolimus or placebo at a daily starting dose of 10 mg.

The study also demonstrated that 97% of trial patients with skin lesions showed 26% response rate with everolimus compared to 0% with placebo, and the time to angiomyolipoma progression was considerably longer in patients on Everolimus.

Novartis Oncology president Hervé Hoppenot said with the FDA approval, Afinitor becomes the first medical option to treat kidney tumours called renal angiomyolipomas and brain tumours such as subependymal giant cell astrocytoma’s (SEGA).

"This approval further strengthens our commitment to address unmet needs in TSC as we continue to research everolimus and mTOR inhibition across other manifestations of the disease," Hoppenot added.

Everolimus has been approved in the EU as Votubia tablets and in the US as Afinitor to treat adult and paediatric patients, aged three years or older, with SEGA associated TSC who require therapeutic intervention but are not candidates or amenable for surgery.

The company said Everolimus is also available for use in other non-oncology patient populations under the brand names Certican and Zortress and is exclusively licensed to Abbott and sublicensed to Boston Scientific for use in drug-eluting stents.


Image: Novartis headquarters in Basel, Switzerland. Photo: Andrew.