Roche today said its Erivedge (vismodegib) has won conditional approval from the European Commission for the treatment of adult patients with symptomatic metastatic basal cell carcinoma (BCC) or locally advanced BCC inappropriate for surgery or radiotherapy. This approval makes Roche’s drug the first licensed medicine for BCC patients in the EU.
Erivedge—a hedgehog pathway inhibitor—earned FDA approval for treatment of patients with advanced BCC in January 2012. Since October 2012, it has also been approved in Switzerland, Australia, Israel, South Korea, Mexico and Ecuador, according to Roche.
“Today’s approval is great news for patients with advanced basal cell carcinoma, who previously had no medicines to treat their disease,” Roche’s Hal Barron, M.D., CMO and head, global product development, said in a statement. “Erivedge substantially reduced tumor size in patients in clinical trials, and we are pleased that Erivedge will now be available to patients in the European Union.”