SILVER SPRING, Md., May 6, 2011 /PRNewswire-USNewswire/ — On
Thursday, the U.S. Food and Drug Administration approved Afinitor
(everolimus) to treat patients with progressive neuroendocrine
tumors located in the pancreas (PNET) that cannot be removed by
surgery or that have spread to other parts of the body
Neuroendocrine tumors found in the pancreas are slow-growing and
rare. It is estimated that there are fewer than 1,000 new cases in
the United States each year.
“Patients with this cancer have few effective treatment
options,” said Richard Pazdur, M.D., director of the Office of
Oncology Drug Products in the FDA’s Center for Drug Evaluation and
Research. “Afinitor has demonstrated the ability to slow the growth
and spread of neuroendocrine tumors of the pancreas.”
The safety and effectiveness of Afinitor was established in a
clinical trial in 410 patients with metastatic (late-stage) or
locally advanced (disease that could not be removed with surgery)
disease. Patients in the study were selected to receive
Afinitor or placebo (sugar pill). The trial was designed to measure
the length of time a patient lived before their disease spread or
worsened (progression-free survival).
In patients treated with Afinitor, the median length of time
they lived without the cancer spreading or worsening was 11 months
compared with 4.6 months in patients who received placebo.
Patients who received placebo were able to receive Afinitor
if their disease worsened.
In patients treated with Afinitor for neuroendocrine pancreatic
tumors, the most commonly reported side effects included
inflammation of the mouth (stomatitis), rash, diarrhea, fatigue,
swelling (edema), stomach (abdominal) pain, nausea, fever, and
Afinitor is also approved to treat patients with ki