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FDA panel backs Novartis cancer drug

Advisors to the US Food and Drug Administration have voted  unanimously in favour of recommending that the federal agency grant marketing approval to Novartis' Afinitor to treat patients with pancreatic cancer

A panel of outside advisors to the US Food and Drug Administration (FDA) has voted unanimously in favour of recommending that the federal agency grant marketing approval to Novartis' Afinitor (everolimus) to treat patients with pancreatic cancer.

Specifically, the Oncologic Drugs Advisory Committee voted in favour of approval of the indication of treatment of advanced neuroendocrine tumours (NET) of pancreatic origin, a deadly condition for which few treatment options currently exist.

About 60 per cent of pancreatic NET patients are diagnosed with advanced disease, meaning that the cancer has spread to other parts of the body, and the five-year survival rate for these patients is 27 per cent, according to Novartis.

The advisory committee voted after a discussion of phase III results that showed that everolimus tablets more than doubled median progression-free survival from 4.6 to 11 months when compared with placebo in patients with advanced pancreatic NET.

The trial programme, known as RADIANT (RAD001 In Advanced Neuroendocrine Tumours), was the largest ever conducted in patients with advanced NET.

The FDA is not required to follow the recommendations of its advisory committees, but it frequently does so.

Everolimus, which targets the mTOR protein, was granted a priority review designation for the treatment of advanced NET of gastrointestinal, lung or pancreatic origin earlier this year. "Based on feedback from the FDA, Novartis amended the proposed indication to focus on patients with one specific type of NET, advanced NET of pancreatic origin," the company noted.

Afinitor received US marketing approval in 2009 to treat patients with advanced renal cancer whose disease has progressed after treatments with other cancer therapies.

13th April 2011

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