(RxWiki News) A newly approved drug may fight one of the most common types of skin cancer.
The US Food and Drug Administration (FDA) today approved a Novartis drug called Odomzo (sonidegib). The drug is approved to treat patients with advanced basal cell carcinoma — a type of skin cancer — that has reappeared after radiation treatment or surgery. Odomzo is also approved for patients who are not candidates for surgery or radiation.
The once-a-day pill works to block a molecular pathway that is active in patients with basal cell cancers. When this path is blocked, basal cell carcinoma may be less likely to grow.
“Our increasing understanding of molecular pathways involved in cancer has led to approvals of many oncology drugs in difficult-to-treat diseases for which few therapeutic options previously existed,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a press release.
While the FDA did approve Odomzo, the Novartis drug does carry a boxed warning that indicates a risk of death or severe birth defects in fetuses of pregnant women who take the drug.
The FDA approved Odomzo after the drug appeared effective in a trial of 194 patients with locally advanced basal cell carcinoma. Among patients treated with 200 milligrams of Odomzo daily, 58 percent saw their tumors shrink or disappear. Patients who received a larger dose — 800 milligrams — made similar progress, but they were more at risk of side effects.
Side effects included hair loss, muscle spasms, fatigue, nausea, diarrhea, stomach pain, vomiting and weight loss.