The FDA today approved vismodegib for the treatment of adults with basal cell carcinoma.
The FDA approval, granted under the agency’s priority review program, allows vismodegib (Erivedge, Genentech) to be used by adults with locally advanced basal cell carcinoma who cannot be treated with radiation or surgery, or those whose disease has spread to other parts of the body.
Vismodegib is the first FDA-approved drug for metastatic basal cell carcinoma, the most common form of skin cancer. Vismodegib — taken once a day — inhibits the Hedgehog pathway, which is active in most basal cell cancers.
“Our understanding of molecular pathways involved in cancer, such as the hedgehog pathway, has enabled the development of targeted drugs for specific diseases,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “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.”
This is a very large milestone in the treatment of this very common malignancy.
Tony Talebi, MD