Basel, April 8, 2011 - Novartis announced today that it has updated its supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for Afinitor (everolimus) tablets. The submission has been amended to only seek approval for the treatment of patients with advanced neuroendocrine tumors (NET) of pancreatic origin. The original submission included a proposed indication for patients with advanced NET of gastrointestinal, lung or pancreatic origin.
The decision by Novartis was based on feedback from the FDA. Novartis remains committed to patients with advanced NET and will continue to conduct studies in patients with advanced carcinoid tumors, where there is a critical unmet need.
The FDA requested that the application be reviewed by the Oncologic Drugs Advisory Committee (ODAC) on April 12, 2011. The FDA can seek the advice of its advisory committees as it reviews and decides whether to approve treatments, however, the recommendations put forth by the group are advisory in nature and do not always reflect the final decisions of the FDA , . There is also the potential that the discussion and outcome of this meeting could result in the FDA extending the review period.
Earlier this year, the FDA granted everolimus priority review designation for the application of advanced NET of GI, lung or 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 for everolimus from 10 to six months. The application is based on data from the RADIANT ( umors) trial program.
Worldwide regulatory filings for everolimus as a treatment for advanced NET of gastrointestinal, lung or pancreatic origin are being reviewed by health authorities. about Afinitor please visit www.afinitor.com/global.