EU grants provisional approval of Erivedge (Roche) for BCC

The EU has granted conditional approval to Erivedge (vismodegib), from Roche, for the treatment of adult patients with symptomatic metastatic Basal Cell Carcinoma (BCC) or locally advanced BCC inappropriate for surgery or radiotherapy. The decision is based on the primary analysis of the pivotal ERIVANCE BCC Phase II study of 104 patients with advanced BCC. It showed Erivedge substantially shrank lesions in 43% of patients with locally advanced BCC and 30% of patients with metastatic BCC, as assessed by independent review. The median duration of response was 7.6 months.

The most common adverse events included muscle spasms, hair loss, altered taste sensation, fatigue and weight loss. The safety profile of Erivedge is being further assessed in STEVIE, a global, open-label multicentre study of patients with advanced BCC.