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news.Novartis has received recommendation from the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) for approval of Afinitor (everolimus) tablets.
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Afinitor tablets are indicated for the treatment of patients with advanced neuroendocrine tumors (NET) of pancreatic origin.
ODAC has recommended the drug on the basis of Phase III RADIANT-3 trial results which demonstrated improvement in progression-free survival with everolimus versus placebo.
Novartis Oncology president Herve Hoppenot said they look forward to working with the FDA as it completes its review and they are encouraged by the advisory committee’s recommendation to approve Everolimus for patients with advanced pancreatic NET.