Tags: US | Panel | Backs | Novartis | Pancreatic | Cancer | Drug

US Panel Backs Novartis' Pancreatic Cancer Drug

Tuesday, 12 Apr 2011 12:46 PM

Novartis AG's cancer drug, Afinitor, showed safety and efficacy in treating a rare type of pancreatic cancer, a U.S. advisory panel said Tuesday.

The 10-member panel voted unanimously in favor of the drug's use in treating patients with advanced pancreatic neuroendocrine tumors.

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 Friday.

The drug is already approved for treating kidney cancer.

While a positive panel vote does not always lead to a regulatory approval, the FDA usually follows panel recommendations.

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Novartis AG's cancer drug, Afinitor, showed safety and efficacy in treating a rare type of pancreatic cancer, a U.S. advisory panel said Tuesday. The 10-member panel voted unanimously in favor of the drug's use in treating patients with advanced pancreatic neuroendocrine...
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