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November 8, 2011

Roche’s skin cancer drug granted priority review by FDA

Roche's new skin cancer drug has been granted "priority review" status by the US Food and Drug Administration (FDA).

Roche’s new skin cancer drug has been granted "priority review" status by the US Food and Drug Administration (FDA).

Vismodegib is an oral medicine designed to treat adults with advanced basal cell carcinoma, the most common form of skin cancer, for whom surgery is inappropriate.

The news comes just three months after Roche’s tumour-shrinking drug Zelboraf was approved to help people who test positive with a genetic mutation known as BRAF, found in half of melanoma patients, to live longer.

The FDA will now review vismodegib, a hedgehog pathway inhibitor, which was shown to "substantially shrink" tumours or heal visible lesions in 43% of patients with locally advanced basal cell carcinoma and 30% of patients with metastatic basal cell carcinoma.

There are currently no effective treatment options for advanced basal cell carcinoma.

Hal Barron, chief medical officer and head of global product development at Roche said, "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.

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"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."

Vismodegib is currently undergoing a Phase II study in the EU and elsewhere.

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