Roche Seeks FDA Approval for Skin Cancer Drug, Frings Says

Roche Holding AG submitted an experimental drug to treat a form of skin cancer to the U.S. Food and Drug Administration for approval.

The filing for vismodegib to treat advanced basal cell carcinoma was based on a study to be presented at the European Multidisciplinary Cancer Congress next week, Stefan Frings, Roche’s oncology head, said in an interview today at the company’s headquarters in Basel, Switzerland.

The drug shrunk tumors and healed lesions in patients whose cancer had progressed too far to be removed with surgery, Roche said in a statement today. There are currently no treatments for those patients, Roche said. The company is also studying vismodegib in people whose cancer is still operable.

The Swiss drugmaker is developing vismodegib under an agreement with Lexington, Massachusetts-based Curis Inc. The U.S. company is eligible to receive $8 million from Roche upon FDA acceptance of the submission, Curis said in a separate statement. Curis also will receive an additional payment if the drug is approved, as well as royalties on any sales.

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