Conditional EU approval for Roche’s Erivedge
The European Commission granted conditional approval to Roche’s Erivedge (vismodegib) for the treatment of adult patients with symptomatic metastatic basal cell carcinoma (BCC) or locally advanced BCC inappropriate for surgery or radiotherapy.
Today’s approval makes Erivedge the first licensed medicine for patients in the European Union with this form of skin cancer.
“Today’s approval is great news for patients with advanced basal cell carcinoma, who previously had no medicines to treat their disease. Erivedge substantially reduced tumour size in patients in clinical trials, and we are pleased that Erivedge will now be available to patients in the European Union.“
Hal Barron MD, Roche’s Chief Medical Officer and Head of Global Product Development.
Roche will provide additional data on Erivedge in advanced BCC from an ongoing global safety study to satisfy the provisions of the conditional approval.
Reference links:
Roche’s Erivedge receives conditional EU approval for treatment of advanced basal cell carcinoma (Press release)
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