Roche seeks FDA approval for vismodegib

BASEL, Switzerland — The Food and Drug Administration has accepted a new drug application for a skin cancer treatment developed by Roche.

Roche said that the FDA accepted its NDA for vismodegib, designed to treat advanced basal cell carcinoma in adults for whom surgery is considered inappropriate. The application was granted priorit review status and has a confirmed action date of March 8, 2012.

“We are pleased the FDA has granted priority review for vismodegib and we look forward to working with the Agency on the review of the data," Roche chief medical officer and head of global product development Hal Barron said. “We hope to provide people with the first FDA-approved medicine for this potentially disfiguring, and in some cases fatal, disease as soon as possible.”

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