EAST HANOVER, N.J., April 12, 2011 /PRNewswire/ — Novartis
Pharmaceuticals Corporation (“Novartis”) announced today 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
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(4,5).
“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 Herve 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%(3,7).
Everolimus targets mTOR, a protein that acts as an important
regulator of tumor cell division, blood vessel growth and cell
metabolism(2). 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