Hard on the heels of securing EU approval for its oral anticancer drug everolimus in pancreatic neuroendocrine tumours, Novartis has also got the go-ahead to market the drug for a form of benign brain tumour.
The European Medicines Agency cleared everolimus yesterday for patients aged 3 years and older with subependymal giant cell astrocytoma (SEGA), a benign tumour type associated with the genetic disease tuberous sclerosis complex,which can cause life-threatening brain swelling.
It will be sold for this indication under the Votubia brand name for SEGA patients whose tumours cannot be treated with surgery, the only therapy currently available for the disease. It has already been approved for this indication in the USA and Switzerland.
The green light was given on the back of a Phase II study which showed that 78% of SEGA patients experienced a 30% or greater reduction in the size of their largest tumour, while 33% experienced a reduction of 50% or greater after six months' treatment. Tuberous sclerosis complex affects 1-2 million people worldwide, and SEGAs occur in around 20% of cases.
"The approval of Votubia in the EU means that for the first time, patients living with SEGA associated with tuberous sclerosis complex will have an effective therapeutic option," said Hervé Hoppenot, President, Novartis Oncology.
Everolimus is also sold under the Afinitor brand name for treating renal cell carcinoma and most recently pancreatic NET, and was the first drug in the mTOR inhibitor class to reach the market. It brought in $192 million in the first six months of this year.
It is also cleared the USA and Europe for the prevention of organ rejection in various transplantation settings as Zortress and Certican, respectively.
Novartis has said it plans to file additional dossiers in oestrogen receptor-positive breast cancer later this year and gastric cancer in 2012. Clinical testing is also being carried out in HER2-positive breast cancer, hepatocellular carcinoma and lymphoma, with filings scheduled from 2013 onwards.