-- Scott Roberts
FRIDAY, May 6 (HealthDay News) -- U.S. Food and Drug
Administration approval of Afinitor (everolimus) has been expanded
to include people with progressive neuroendocrine tumors of the
pancreas (PNET) that have spread to other parts of the body or
cannot be removed by surgery, the agency said Friday.
PNET is slow-growing and rare, affecting fewer than 1,000 new
patients in the United States each year, the FDA said in a news
Afinitor was evaluated in clinical trials involving 410 people
with late-stage or advancing forms of this cancer. Those treated
with Afinitor survived without the cancer worsening for an average
of 11 months, compared with 4.6 months among people who took a
placebo, the agency said.
The most common side effects reported included mouth
inflammation, rash, diarrhea, fatigue, swelling, stomach pain,
nausea, fever and headache.
Afinitor was previously FDA-approved for advanced kidney cancer
and certain brain tumors that cannot be treated surgically.
The drug is marketed by Novartis, based in East Hanover,
The FDA has more about
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