Novartis drug Afinitor recommended by FDA oncology advisory committee for approval to treat advanced NET of pancreatic origin

15-Apr-2011 - Switzerland

Novartis announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of Afinitor® (everolimus) tablets for the treatment of patients with advanced neuroendocrine tumors (NET) of pancreatic origin.

The recommendation was provided after presentation of data from the everolimus RADIANT (RAD001 In Advanced Neuroendocrine Tumors) trial program, the largest conducted in patients with advanced NET. The Phase III RADIANT-3 trial studied patients with advanced NET of pancreatic origin and showed a statistically significant improvement in progression-free survival with everolimus versus placebo.

The FDA can seek the advice of its advisory committees as it reviews and decides whether to approve treatments, although it is not obliged to follow the recommendation.

"We look forward to working with the FDA as it completes its review and we are encouraged by the advisory committee's recommendation to approve everolimus for patients with advanced pancreatic NET," said Hervé Hoppenot, President, Novartis Oncology. "The study of everolimus in this patient population is an example of our commitment to identify targeted options for patients with critical unmet medical needs."

When pancreatic NET becomes advanced, meaning the cancer has spread to other parts of the body, it is considered aggressive and difficult to treat[6]. Approximately 60% of pancreatic NET patients are diagnosed with advanced disease, and the five-year survival rate for these patients is 27%.

Everolimus targets mTOR, a protein that acts as an important regulator of tumor 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 tumors, including advanced pancreatic NET, for which there are limited treatment options.

Earlier this year, the FDA granted everolimus priority review designation for the application and proposed indication for the treatment of advanced NET of gastrointestinal (GI), lung or pancreatic origin. Based on feedback from the FDA, Novartis amended the proposed indication to focus on patients with one specific type of NET, advanced NET of pancreatic origin.

Priority review status is granted to therapies that offer major advances in treatment or provide a treatment where no adequate therapy exists. This status accelerates the standard review time from 10 to six months. There is the potential that the outcome of an ODAC meeting could result in the FDA extending the review period.

Worldwide regulatory filings for everolimus as a treatment for advanced NET of GI, lung or pancreatic origin are being reviewed by health authorities.

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