The US Food and Drug Administration (FDA) has approved everolimus (Afinitor) to treat patients with advanced pancreatic neuroendocrine tumors (pNETs).
pNETs is a rare, slow-growing form of pancreatic cancer. In theUnited States, there are fewer than 1000 new pNET cases reported each year.
The approval is based on results from the clinical trial, RADIAN-3, which included 410 patients with metastatic or locally advanced disease.
Patients who received everolimus experienced a median of 11 months before tumor growth compared with 4.6 months in patients who were given a placebo. Furthermore, patients who took everolimus experienced a 65% lower risk for cancer progression than patients receiving placebo.
The most commonly reported adverse effects associated with everolimus included stomatitis, rash, diarrhea, fatigue, edema, abdominal pain, nausea, fever, and headache.
Everolimus, which inhibits mTOR (an enzyme that regulates cell growth and proliferation), has already been approved for patients with advanced renal cell carcinoma in whom treatment with sunitinib (Sutent) or sorafenib (Nexavar) has failed.
It is also prescribed for patients with subependymal giant cell astrocytoma that is associated with tuberous sclerosis and cannot be treated surgically.
Source: http://www.fda.gov
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