Novartis AG's cancer drug, Afinitor, showed safety and efficacy in treating a rare type of pancreatic cancer that has few treatment options, a U.S. advisory panel said on Tuesday.
The 10-member panel voted unanimously in favor of the drug's use in treating patients with advanced pancreatic neuroendocrine tumors.
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While panelists were concerned that Afinitor had shown serious side effects, they agreed that the benefits that could be offered by the drug to patients suffering from the rare cancer outweighed the risks.
Some panelists suggested addressing the problem of observed side effects on the drug's label.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.
"Pancreatic neuroendocrine tumor is a relatively rare cancer representing about $100 million of peak sales potential, less than 1 percent to Novartis' core earnings per share," Deutsche Bank analyst Tim Race said.
He said the drug could see sales of about $2 billion from other indications, including breast, gastric and liver cancers.
Last Friday, the U.S. Food and Drug Administration staff questioned Novartis' findings on the benefits of the drug and the Swiss drugmaker narrowed the approval application after the reviewer's comments.
One study showed Afinitor extended the time it took the cancer to worsen in patients with advanced neuroendocrine tumors. The other study in patients with similar tumors missed its predefined statistical test for showing benefit, the FDA reviewers said on Friday.
While a positive panel vote does not always lead to a regulatory approval, the FDA usually follows panel recommendations.
Pancreatic neuroendocrine tumors are rare, with a strike rate of about 0.32 case per 100,000 people. They usually grow slower than other pancreatic cancers that kill within months of diagnosis.
Both types have few treatment options.
Novartis shares were trading up 0.2 percent at $55.29 in afternoon dealings on the New York Stock Exchange.
(Reporting by Esha Dey; editing by Andre Grenon and Gerald E. McCormick)
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