Novartis Gains Afinitor Approval

8 May 2011 (Last Updated May 8th, 2011 18:30)

Novartis has received US Food and Drug Administration approval for its Afinitor tablets, used in the treatment of progressive neuroendocrine tumours. The approval, the first for a treatment for the target patient population in the US in almost 30 years, was based on data obtained fro

Novartis has received US Food and Drug Administration approval for its Afinitor tablets, used in the treatment of progressive neuroendocrine tumours.

The approval, the first for a treatment for the target patient population in the US in almost 30 years, was based on data obtained from a Phase III clinical trial that showed Afinitor more than doubled the time without tumour growth.

The drug was also found to reduce the risk of cancer progression by 65% when compared to placebo in patients with advanced pancreatic neuroendocrine tumours.

Afinitor works by targeting mTOR, a protein that acts as an important regulator of tumour cell division, blood vessel growth and cell metabolism.