FDA Accept and File Roche’s Skin Cancer Drug, Vismodegib

Roche announced today that regulators in the USA have given a priority review status to their investigational skin cancer drug, vismodegib, for the treatment of adults with advanced basal cell carcinoma (BCC) for whom surgery is considered unsuitable.  The priority review means that the U.S. Food and Drug Administration has set an action date to decide on approval of  vismodegib for March 8, 2012.

Vismodegib is a first-in-class oral treatment that selectively inhibits signalling in the Hedgehog pathway, “which is implicated in more than 90% of BCC cases,” Roche notes.

Basal cell carcinoma is the most common type of skin cancer, which is normally considered curable by surgery.  However, when it advances, it can cause disfiguring and debilitating effects and can be life-threatening.  Currently, there are no effective treatment options for advanced basal cell carcinoma.

Hal Barron, M.D., Chief Medical Officer and Head, Global Product Development, commented that Roche “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.”  He added “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.”

The application is based on results from the pivotal ERIVANCE BCC study, which showed vismodegib substantially shrank tumours or healed visible lesions in 43% of patients with locally advanced BCC and 30% of patients with metastatic BCC.  The median progression-free survival for both metastatic and locally advanced BCC patients was 9.5 months.

The acceptance by the FDA triggers an $8 million milestone payment to US biotech Curis, vismodegib’s originator.  Roche are currently conducting a Phase II safety study in the EU and other countries.

The news follows the recent FDA approval granted to Roche’s Zelboraf (vemurafenib), a personalised medicine designed for use in melanoma patients whose tumours express a gene mutation called BRAF V600E.



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