FDA Panel Backs PegIntron as Skin Cancer Treatment
Even though it carries toxic risks, the drug PegIntron should be approved for treatment of patients with late-stage skin cancer that's spread to the lymph nodes and requires surgery, a U.S. Food and Drug Administration advisory panel decided Monday.
Studies by drug maker Schering-Plough showed that treatment with the drug delayed cancer recurrence by about nine months. However, patients who received PegIntron didn't live longer than those who weren't given the drug, the Associated Press reported.
Forty-four percent of patients dropped out of the study due to the drug's toxic side effects such as nausea, skin reactions and fatigue. Even so, the FDA panel decided in a 6-4 vote that the drug's benefits outweigh its side effects.
"I'm leaning in the direction that this may be helpful given that there are very few options for these patients," said panel chair Dr. Gary Lyman, of Duke University Medical Center, the AP reported.
Even though it's not required to, the FDA usually follows the recommendations of its expert panels. PegIntron is already approved in the U.S. as a treatment for hepatitis C.
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