The U.S. Food and Drug Administration (FDA) on Monday approved Erivedge (vismodegib) to treat adult patients with basal cell carcinoma, the most common type of skin cancer.
Erivedge, reviewed under the agency's priority review program, is the first FDA-approved drug for metastatic basal cell carcinoma. Basal cell carcinoma is generally a slow growing and painless form of skin cancer that starts in the top layer of the skin. The cancer develops on areas of skin that are regularly exposed to sunlight or other ultraviolet radiation.
Erivedge is a pill taken once a day and works by inhibiting the Hedgehog pathway, a pathway that is active in most basal cell cancers and only a few normal tissues, such as hair follicles.
"Our understanding of molecular pathways involved in cancer, such as the Hedgehog pathway, has enabled the development of targeted drugs for specific diseases," said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "This approach is becoming more common and will potentially allow cancer drugs to be developed more quickly. This is important for patients who will have access to more effective therapies with potentially fewer side effects."
According to the FDA, the most common side effects observed in patients treated with Erivedge were muscle spasms, hair loss, weight loss, nausea, diarrhea, fatigue, distorted sense of taste, decreased appetite, constipation, vomiting, and loss of taste function in the tongue.