Novartis gets FDA approval for pancreatic cancer drug

Fri May 6, 2011 1:49am EDT

* U.S. advisory panel had recommended drug's use

* Afinitor seen as future blockbuster

ZURICH, May 6 (Reuters) - Novartis AG's (NOVN.VX) (NVS.N) cancer drug Afinitor has been approved by the U.S. Food and Drug Administration for a rare type of pancreatic cancer that has few treatment options.

"Data show Afinitor delays tumour growth and reduces risk of disease progression in patients with advanced neuroendocrine tumours (NET) of pancreatic origin," the Swiss drugmaker said in a statement.

"This marks the first approval of a treatment for this patient population in the United States in nearly 30 years."

Last month, a U.S. advisory panel voted unanimously in favour of the drug's use in treating patients with advanced pancreatic neuroendocrine tumours, despite concerns about serious side effects. [ID:nN12179016]

Afinitor is already approved for treating kidney cancer and is expected to rake in sales of $1.3 billion in 2015, according to a Thomson Reuters forecast.

In April FDA staff questioned Novartis' findings on the benefits of the drug, and the Swiss drugmaker narrowed the approval application after the reviewer's comments.

Novartis said it had also submitted applications for Afinitor use for pancreatic cancer to the European Medicines Agency and the Swiss regulator.

Pancreatic neuroendocrine tumours are rare, with a strike rate of about 0.32 case per 100,000 people. They usually grow more slowly than other pancreatic cancers that kill within months of diagnosis. Both types have few treatment options. (Reporting by Emma Thomasson; Editing by David Cowell)

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