A Marketing Authorization Application for vismodegib has been submitted to the European Medicines Agency for the treatment of adults with advanced basal cell carcinoma, for whom surgery is considered inappropriate. Vismodegib is a first-in-class, investigational, oral medicine designed to selectively inhibit signalling in the Hedgehog pathway and is being developed by Roche and Genentech. The application is based on clinical data from a phase II study (ERIVANCE BCC/SHH4476g).