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Vismodegib Capsule Approved for Metastatic Basal Cell Carcinoma

TOP - February 2012, Vol 5, No 1 published on February 28, 2012 in FDA Updates

The FDA approved Erivedge (vismodegib; Genentech) capsule for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred after surgery or who are not candidates for surgery, and who are not candidates for radiation. Basal cell carcinoma is the most common type of skin cancer, and vismodegib is the first drug approved by the FDA for metastatic basal cell carcinoma.

Vismodegib inhibits the hedgehog pathway, a channel used by cells to communicate. Malfunctions in the hedgehog pathway are thought to play a role in several types of cancer, and this pathway is a focus of research. The hedgehog pathway is crucial to embryonic development.

The most common adverse reactions (≥10%) for vismo­degib were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia. Three of 10 premenopausal women developed amenorrhea in clinical trials. Vismodegib approval carries a black box warning for the risk of fetal death or severe birth defects.

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Last modified: July 22, 2021