The Lynx Group

Erivedge First Drug Ever for Metastatic Basal-Cell Carcinoma

February 2012, Vol 3, No 1

The US Food and Drug Admin­istration (FDA) approved vismodegib (Erivedge; Hoffmann–La Roche), a hedgehog pathway inhibitor, for the treatment of basal-cell carcinoma (BCC) in adults with locally advanced disease who are not candidates for surgery or radiotherapy and in those with metastatic disease. Approved under a priority review, oral vismodegib is the first FDA approved drug with an indication for this condition. 

“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, MD, Director, FDA’s Office of Hematology and Oncology Products.

The approval was based on a single, multicenter clinical trial of 96 patients with locally advanced or metastatic BCC. After a median treatment of 10.2 months, 30% of patients with meta­static BCC and 43% of those with locally advanced disease had a complete or partial response, the study’s primary end point.

The most common adverse effects were muscle spasms, hair loss, weight loss, nausea, diarrhea, fatigue, dysgeusia, decreased appetite, constipation, and vomiting. The recommended dose is 150 mg/day.

Vismodegib has a boxed warning about the risk for death or severe birth defects to a fetus. Pregnancy status must be checked before beginning treatment with this drug. (January 30, 2012)

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