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Novartis gains FDA approval for Afinitor®


  • Data show Afinitor delays tumour growth and reduces risk of disease progression in patients with advanced neuroendocrine tumours (NET) of pancreatic origin
  • Afinitor represents a new approach to treat advanced pancreatic NET, an aggressive cancer for which there has been limited treatment options
  • Regulatory filings outside the US have been submitted for everolimus in advanced NET and are being reviewed by health authorities worldwide

Novartis announced today that the US Food and Drug Administration (FDA) approved Afinitor® (everolimus) tablets for the treatment of progressive neuroendocrine tumours of pancreatic origin (PNET) in patients with unresectable, locally advanced ormetastatic disease. This marks the first approval of a treatment for this patient population in the US in nearly 30 years.

The approval was based on Phase III data from the RADIANT-3 (RAD001 In Advanced Neuroendocrine Tumours) trial showing treatment with Afinitor more than doubled the time without tumour growth (median 4.6–11.0 months) and reduced the risk of cancer progression by 65% when compared with placebo in patients with advanced pancreatic NET (hazard ratio=0.35 [95% confidence interval (CI), 0.27 to 0.45]; p<0.001). A consistent improvement in progression-free survival was seen with Afinitor in all patient subgroups. The FDA determined that the safety and effectiveness of Afinitor in the treatment of patients with carcinoid tumours have not been established.

“The FDA approval of Afinitor represents an important step forward for patients with advanced pancreatic NET,” said James Yao, MD, Associate Professor of Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.

“Patients will now have access to a treatment that has been shown to significantly delay tumour growth and reduce the risk of disease progression.”

Approximately 60% of pancreatic NET patients are diagnosed with advanced disease. This means that the cancer has already spread to other parts of the body, and is considered aggressive and difficult to treat. The five-year survival rate for these patients is 27%.

“With this approval, US physicians can now offer their patients with progressive pancreatic NET a new treatment helping to fulfil a critical unmet need,” said Hervé Hoppenot, President, 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 tumour types.”

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

Novartis has submitted marketing applications for everolimus for the treatment of patients with advanced NET of gastrointestinal, lung or pancreatic origin to the European Medicines Agency (EMA) and the Swiss Agency for Therapeutic Products (Swissmedic), and additional regulatory submissions are being reviewed by health authorities worldwide.


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