Erivedge (vismodegib) for Advanced Basal Cell Carcinoma

Erivedge® (vismodegib) is a first-in-class orally-administered small molecule which is designed to selectively inhibit the Hedgehog signaling pathway by targeting a protein called Smoothened. Genetic mutations that lead to unregulated activation of Hedgehog signaling are found in basal cell carcinoma (BCC) and medulloblastomas. Aberrant signaling in the Hedgehog pathway is implicated in over 90% of BCC cases.

Erivedge® is being developed and commercialized by Roche and Genentech under a 2003 collaboration agreement between Curis and Genentech whereby Genentech obtained an exclusive, global, royalty-bearing license with the right to sublicense, to make, use, sell and import small molecule and antibody Hedgehog pathway inhibitors for human therapeutic applications, including cancer therapy.

Erivedge® is approved for use in patients with advanced BCC in the U.S., the 28-member states of the European Union, and several other countries worldwide. It is also under regulatory review for commercialization in a number of additional territories.

BCC is the most common type of skin cancer in Europe, Australia and the United States. The American Cancer Society estimates that each year approximately 2 million people in the U.S. are diagnosed with non-melanoma skin cancer. Most of these are basal cell carcinomas. The majority of BCC lesions are localized to a small area of the skin and are routinely addressed with surgery. In advanced BCC, which are estimated to account for approximately 1.5% of the diagnosed patients1, the lesion has either recurred in the same location after surgery or radiotherapy, or it may have advanced further into surrounding areas such as sensory organs (ears, nose and eyes), bone or other tissues.

Posters and Presentations

1Dacosta-Byfield S, et al., Cost and patterns of care among patients with advanced non-melanoma skin cancer. Journal of Clinical Oncology 29(15_suppl):e16517-e16517.

ERIVEDGE is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation.