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GEN News Highlights : May 11, 2011

Switzerland Clears Novartis’ Everolimus for Treating SEGA

Phase II registrational study showed 75% of patients experienced at least 30% reduction in SEGA tumor size.

The Swiss regulatory authorities approved Novartis’ Votubia® (everolimus) tablets for treating subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS) in patients aged three years and over who are not suitable for surgery. The drug is the first to be approved in Switzerland for this indication. In the U.S. everolimus is marketed as Afinitor® for the SEGA indication. An equivalent regulatory review is in progress in the EU.

Clearance of Votubia for the treatment of SEGA by the Swiss authorities was based on a prospective, open-label Phase II study in 28 patients, which showed that treatment with Votubia led to 75% of participants experiencing at least a 30% reduction in the size of their largest SEGA. Thirty-two percent of patients experienced a size reduction of 50% or more at six months. Of 16 patients who experienced seizures at the start of the trial, nine demonstrated decreases in seizure frequency as a result of Votubia therapy. Facial angiofibromas also improved in 87% of patients at six months.

The new approval in Switzerland follows within days of FDA granting U.S. approval for Afinitor as a treatment for progressive neuroendocrine tumors of pancreatic origin (pNET) in patients with unresectable, locally advanced, or metastatic disease. Everolimus is currently approved in various markets for pancreatic NET, SEGA, and renal cell carcinoma indications, and for preventing organ rejection in adult kidney and heart transplant patients.