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FDA approves Genentech skin cancer drug


SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating the most common type of skin cancer, the agency said Monday.

The FDA announced the approval of Genentech's Erivedge (vismodegib) for adults with basal cell carcinoma who are not surgery or radiation therapy candidates and whose disease is locally advanced or has spread to other parts of the body.

The drug works by inhibiting the Hedgehog pathway, which is active in most basal cell cancers and only a few normal tissues, such as hair follicles. The disease generally is a slow-growing and painless cancer that starts in the top layer of the skin and develops in areas regularly exposed to sunlight or other ultraviolet radiation.

"Our understanding of molecular pathways involved in cancer, such as the Hedgehog pathway, has enabled the development of targeted drugs for specific diseases," FDA Office of Hematology and Oncology Products director Richard Pazdur said. "This approach is becoming more common and will potentially allow cancer drugs to be developed more quickly."


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