Roche's Erivedge gets EU conditional approval
This article was originally published in Scrip
The EU has granted a conditional approval to Roche's hedgehog pathway inhibitor Erivedge (vismodegib) for use in advanced basal cell carcinoma following a CHMP positive opinion in April, making it the first once-daily capsule treatment for this indication.
The approval specifically covers the treatment of symptomatic metastatic basal cell carcinoma (BCC) or locally advanced BCC inappropriate for surgery or radiotherapy (scripintelligence.com, 26 April 2013). Under the provisions of the conditional approval, Roche will provide additional data on Erivedge in advanced BCC from the ongoing multinational safety study, STEVIE, in 1,200 patients. An interim analysis from STEVIE presented at ASCO confirmed a similar safety profile to that observed in the pivotal Phase II ERIVANCE BCC study, which formed the basis for the conditional approval.
Erivedge became the first licensed medicine for patients with advanced basal cell carcinoma in January 2012 when the US FDA approved it under the priority review programme, and it has subsequently been approved in Switzerland, Australia, Israel, Mexico, Israel, Ecuador and South Korea. Submissions have been made elsewhere, with more planned.
Roche has not given Scrip any details as to its launch plans for the product in the EU.