Novartis cancer drug receives EU OK for new use
A cancer treatment from Novartis received approval to be sold in Europe as a treatment for some patients with non-cancerous kidney tumors from a rare genetic disorder.
The European Commission approved tablets of Votubia , which are sold under the brand name Afinitor in the United States, to treat adult patients with tumors associated with tuberous sclerosis complex who do not need surgery immediately, the Swiss drugmaker said Monday.
Tuberous sclerosis causes tumors in the brain, eyes, lungs, liver and other organs, leading to learning disabilities, seizures and other problems. The tumors are not cancerous, but they can lead to severe internal bleeding, kidney failure and cardiovascular diseases, among other problems.
The drug also has been approved in the United States to treat the same condition. It also is approved to treat forms of lung and pancreatic cancers. In August, the FDA cleared a new formulation of Afinitor to treat young patients with brain tumors caused by tuberous sclerosis.