A drug which is usually used for treatment of an advanced form of kidney cancer is now approved by the United States, to be used for treatment of brain tumors. Everolimus, the drug under the name Afinitor by Swiss pharmaceutical giant Novartis, is now approved to treat tumors caused by the genetic condition tuberous sclerosis that cannot be cured by surgery, the US Food and Drug Administration (FDA) and Novartis said.

The disease is known to cause slow-growing non-cancerous tumors called subependymal giant cell astrocytoma (SEGA) in the brain, and might also lead to tumors in various other parts of the body. This disorder which is proved to be genetic might affect teens and children more often than adults, and might also lead to deaths. "Patients with this disease currently have limited treatment options beyond surgical intervention," said Richard Pazdur, director of the Office of Oncology Drug Products in the FDA Center for Drug Evaluation and Research.

After the study, it was approved to treat SEGA tumors under the FDA's accelerated approval program.

Those participating in the study at Cincinnati Children's Hospital did not suffer from new tumors, but, none of the tumors were healed earlier. Researchers noted that four patients, who had undertaken surgery earlier had their tumors, grow back. After taking Afinitor, FDA noted that three of those patients saw a reduction in tumor volume of more than 50 per cent.

Commonly reported side effects included upper respiratory tract infections, sinus and ear infections, mouth sores and fever.Between 25,000 and 40,000 people in the United States are affected by tuberous sclerosis, and SEGA tumors occur in up to 20 percent of them, Novartis said.The company is carrying out a Phase III trial with patients in Australia, Belgium, Britain, Canada, Germany, Italy, the Netherlands, Poland, Russia and the United States.

Afinitor, which brought in 70 million dollars in sales last year and has already, reaped 67 million dollars in sales in the first three quarters of 2010, Afinitor brought in $70 million sales in the previous year, and earned $67 million in the first three quarters of 2010. It was initially agreed to be used in the United States in March last year to treat kidney cancer in patients in whom other treatments had failed.

The drug is also accepted in the European Union and the United States, for treatment of kidney cancer, and in different dosages and under different names to Afinitor for the prevention of organ rejection among heart and kidney transplant patients.

It hasn’t received any approval to be used outside United States, for treatment of the brain cancer.

"Because of the uncertainty of clinical trials, there is no guarantee that everolimus will become commercially available for SEGAs anywhere else in the world," the company added.