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FDA Grants Approval for First Skin Cancer Drug


The U.S. Food and Drug Administration approved the first drug to treat basal cell carcinoma, the most common form of skin cancer, on Monday.

Erivedge (vismodegib), marketed by San Francisco-based Genentech, won expedited FDA approval under a priority review program for drugs that may represent a major treatment advance. In a statement, the agency said the once-daily pill treats basal cell skin cancer that has metastasized, or spread, and is designed for cases deemed unsuitable for surgery or radiation.

Basal cell carcinoma, which is usually a slow-growing and painless form of cancer, starts in the top layer of skin and is typically caused by frequent exposure to sunlight and other forms of ultraviolet radiation. Estimates say one in five Americans will develop it in their lifetime — but caught early, it’s highly treatable.

Researchers evaluated the safety and effectiveness of Erivedge in a clinical study of 96 people with locally advanced or metastatic cancer. In the latter group, 30 percent had at least a partial response to the drug, while 43 percent of people with locally advanced basal cell had at least a partial response.

Side effects of Erivedge included muscle spasms, hair loss, weight loss, nausea, diarrhea, fatigue, distorted sense of taste, decreased appetite, constipation and vomiting. Because of the potential risk for death or severe birth defects to a fetus, the drug will be packaged with a label warning and won’t be prescribed to pregnant women.

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