FDA Approves New Drug for Locally Advanced Skin Cancer

By Kristin J. Kelley

Edited by Susan Sadoughi, MD

Sonidegib (brand name: Odomzo) has been approved for the treatment of locally advanced basal cell carcinoma. It is indicated for adults for whom surgery or radiation isn't an option, or whose cancer returned after those treatments.

Approval for the once-daily pill — which reduces the growth of cancerous lesions by blocking the Hedgehog pathway — was based on a randomized trial of nearly 200 patients with locally advanced basal cell carcinoma. Roughly 58% of patients who took 200 mg or 800 mg of sonidegib experienced the primary endpoint — shrinkage or disappearance of tumors; the effect lasted over 6 months in half these patients.

Sonidegib will have a boxed warning about the potential risk for severe birth defects or death to fetuses.