FDA approves Novartis pancreas cancer drug

Novartis AG’s 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 tumor growth and reduces risk of disease progression in patients with advanced neuroendocrine tumors (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 favor of the drug’s use in treating patients with advanced pancreatic neuroendocrine tumors, despite concerns about serious side effects.

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 tumors are rare, with a strike rate of about 0.32 cases 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.

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(Reuters)