EU grants full approval for Erivedge (vismodegib) to treat metastatic basal cell carcinoma.- Genentech + Roche

Curis, Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted full approval to Erivedge (vismodegib) for the treatment of adult patients with symptomatic metastatic basal cell carcinoma (BCC) or locally advanced BCC inappropriate for surgery or radiotherapy. Erivedge is also approved in the U.S. 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. Erivedge was developed and is marketed by Roche and Genentech, a member of the Roche Group, under a collaboration agreement between Curis and Genentech.

Erivedge was originally granted ‘conditional approval' in July, 2013 in the European Union (EU) and the authorization has now been converted from ‘conditional' to ‘full approval' based on the results from the STEVIE study that included 1215 patients with advanced BCC. STEVIE (MO25616) is a single-arm, open-label, Phase II, multicenter study that was conducted by Roche to assess the safety of vismodegib in patients with locally advanced and metastatic BCC. The safety and efficacy results of the STEVIE trial were consistent with the results of the pivotal study ERIVANCE BCC (SHH4476g) that supported the initial conditional approval of the drug in the EU.