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Novartis Gains FDA Approval for Afinitor® as First New Treatment in Nearly Three Decades for Patients with Advanced Pancreatic NET
Date:5/5/2011

, Novartis Oncology. "This is the third indication for Afinitor in the US in just over two years, providing further evidence that inhibiting mTOR plays an important role in treating multiple tumor types."

Afinitor targets mTOR, a protein that acts as an important regulator of tumor cell division, blood vessel growth and cell metabolism(7). Preclinical and clinical data have established the role of mTOR in the development and progression of several types of tumors, including advanced pancreatic NET(1),(7).

About neuroendocrine tumors of pancreatic origin (pancreatic NET)Neuroendocrine tumors arise from cells that can produce and secrete a variety of hormones that regulate bodily functions(8). These tumors can occur anywhere in the body; however, most are found in the pancreas (pancreatic NET), gastrointestinal tract or lungs (carcinoid tumors)(6),(9). Pancreatic NET, also known as islet cell tumors, is a rare type of cancer different from pancreatic exocrine cancer, which is generally referred to as pancreatic cancer(3),(10). There have been limited treatment options for patients with pancreatic NET(2).

About RADIANT-3RADIANT-3 is a Phase III prospective, double-blind, randomized, parallel group, placebo-controlled, multicenter study. The trial examined the efficacy and safety of Afinitor plus best supportive care (BSC) versus placebo plus BSC in 410 patients with advanced, low- or intermediate-grade pancreatic NET. Patients who met the study entry criteria were randomized 1:1 to receive either Afinitor 10 mg once-daily (n=207) or daily placebo (n=203) orally, both in conjunction with BSC(1).

The primary endpoint of RADIANT-3 is progression-free survival. Secondary endpoints include safety, objective response rate (confirmed according to RECIST), duration of response and overall survival(1).

About Afinitor (everolimus)Afinitor® (everolimus) tablets is approved in the US for the treatment of progressive neuroe
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