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FDA panel backs Schering-Plough cancer drug
 
 
  (AP) Oct 5 2009
 
GAITHERSBURG, Md. - Federal health advisers have voted 6-4 that the potential benefits of a Schering-Plough drug used to treat late-stage skin cancer outweigh its toxic risks.
 
Schering has asked the Food and Drug Administration to approve PegIntron for patients whose skin cancer has spread to their lymph nodes, requiring surgery. The drug is already approved as a treatment for hepatitis C.
 
Company studies of the drug showed it lengthened the period of time before cancer recurred, though patients ultimately didn't live longer.
 
PegIntron caused high levels of toxicity, and 44 percent of patients dropped out of the study due to toxic side effects like fatigue, nausea and skin reactions.
 
The FDA is not required to follow the advice of its panel of cancer experts, though it usually does.
 
 
 
 
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