European regulators cleared Novartis' Votubia (everolimus) as a treatment for patients aged 3 years and older with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex who are not candidates for curative surgical resection, the company reported Thursday. Hervé Hoppenot, president of the drugmaker's oncology unit, noted that the approval "means that for the first time, patients living with SEGA associated with tuberous sclerosis complex will have an effective therapeutic option."
The company said the decision followed a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in June on its marketing application. Novartis added that the approval was based on data from a mid-stage trial involving 28 patients, which showed that 78 percent experienced a 30 percent or greater reduction in the size of their largest SEGA at six months compared to baseline. In addition, 33 percent of patients experienced a reduction of 50 percent or greater over the same period.
The mTOR inhibitor was approved last year for this indication in the US, where it is sold under the name Afinitor. According to Bank Vontobel analyst Andrew Weiss, the drug may generate annual sales of approximately $300 million in this indication.
The therapy is already approved in the US and Europe for the treatment of patients with advanced renal cell carcinoma and for use in people with certain tumours of pancreatic origin. The drug is also cleared in the two markets for the prevention of organ rejection in certain patients under the brands Zortress and Certican, respectively.
In July, Novartis indicated that it would seek regulatory approval for the drug in breast cancer, and research is also under way in liver and gastric cancer. Helvea analyst Karl-Heinz Koch noted that "so far our peak sales forecasts of $2.7 billion reflects the approved indications of second-line renal cell carcinoma, [brain tumour and cancer of pancreatic origin and second-line breast cancer]." However, he added that "we have not yet reflected the use of the drug in liver, gastric and first-line breast cancer, with results expected during 2012 to 2014, which, if positive, could double our current forecast."
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