U.S. Food and Drug Administration approval for Afinitor (everolimus) has been expanded to include persons with the neuroendocrine tumors progressive of the pancreas (PNET) spread in other parts of the body or can not be removed by surgerythe Agency said Friday.
PNET growth slow and rare, affecting less than 1 000 new patients to the United States each year, the FDA said in a press release.
Afinitor was evaluated in clinical trials involving 410 people with late or advance forms of cancer. Those treated with Afinitor survived without the aggravation of cancer for an average of 11 months, compared to 4.6 months among those who took a placebo, the Agency said.
The most frequently reported side effects inflammation included mouth, rash, diarrhea, fatigue, swelling, pain in the stomach, nausea, fever and headache.
Afinitor was previously FDA approved for advanced kidney cancer and certain brain tumours which cannot be treated surgically.
The drug is marketed by Novartis, based in East Hanover, NJ
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