Swiss drugmaker Roche and drug developer Curis Inc. said Monday that Roche has asked the Food and Drug Administration to approve the drug vismodegib as a treatment for the most common type of skin cancer.
Roche's Genentech unit filed for marketing approval of vismodegib as a treatment for advanced basal cell carcinoma. Curis said around 2 million cases of basal cell carcinoma are diagnosed in the U.S. per year, and the disease is usually curable when it only affects a small area of the skin. Vismodegib is intended for patients who haven't been treated or whose cancer progressed in spite of treatment. It is an oral drug that blocks a pathway involved in more than 90 percent of cases of the disease.
In studies, the drug significantly shrank tumors or reduced lesions in 43 percent of patients with locally advanced cancer, and 30 percent of patients whose cancer had metastasized. The companies said the most common side effects of treatment with vismodegib were muscle spasms, hair loss, changes in taste, weight loss, fatigue, nausea, decreased appetite, and diarrhea.
Vismodegib is Genentech's second submission this year for a skin-cancer treatment. If the FDA accepts the submission, Genentech will pay Curis $8 million. Genentech is also preparing to file for approval of vismodegib in the European Union. Vismodegib was discovered by Genentech, which is based in San Francisco. Curis, of Lexington, Mass., is a drug development company that helped in preclinical studies.
Shares of Curis rose 7 cents, or 2.4 percent, to $2.98 in morning trading.