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Afinitor Phase III Trial Meets Endpoint

Novartis Pharmaceuticals Corp.’s Phase III study of Afinitor (everolimus) tablets plus best supportive care met its primary endpoint in patients with advanced pancreatic neuroendocrine tumors (NET).

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Novartis Pharmaceuticals Corp.’s Phase III study of Afinitor (everolimus) tablets plus best supportive care met its primary endpoint in patients with advanced pancreatic neuroendocrine tumors (NET). Results showed that the drug significantly extended progression-free survival, or time without tumor growth. Currently, surgery and chemotherapy are the only approved treatment options for patients with advanced pancreatic NET.

Everolimus is approved under the trade name Afinitor (everolimus) tablets for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib.

“Everolimus was developed to inhibit the mTOR protein, which is a critical target in treating various cancers, including NET. Results from RADIANT-3 demonstrate that everolimus has the potential to become an important treatment option for patients with advanced pancreatic NET, where there is a major unmet need,” said Herve Hoppenot, president, Novartis Oncology. “These study results will serve as the basis of worldwide regulatory filings for everolimus and bring us one step closer to our goal of offering these patients a new therapy.”

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