Extended survival in clinical studies
Friday, May 6, 2011 (Last Updated: 05/09/2011)
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 release.
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 stomatitis, rash, diarrhea, fatigue, edema, 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, N.J.
The FDA has more about this approval.
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