FRIDAY, July 24, 2015 (HealthDay News) -- Odomzo (sonidegib) has been approved by the U.S. Food and Drug Administration to treat basal cell carcinoma skin cancer that has returned despite surgery or radiation.
The treatment is sanctioned for people who are not candidates for additional surgery or radiation.
Basal cell carcinoma accounts for about 80 percent of skin cancers that are not melanoma, a more deadly form of the disease. Basal cell starts in the top layer of skin, usually in areas that are most exposed to the sun, the agency said Friday in a news release.
The once-daily pill is designed to inhibit a process that promotes the growth of cancerous lesions.
The drug's label includes a boxed warning that it may cause death or severe birth defects in a growing fetus. Women who may become pregnant should verify pregnancy status before taking the drug. And both males and females who take Odomzo are advised to use contraception, the agency said.
The drug was evaluated in a clinical study involving 66 people. Some 58 percent of people treated with 200 milligrams of Odomzo had their tumors shrink or disappear, the FDA said. The most common side effects included muscle spasms, hair loss, distorted taste, fatigue, nausea, muscle and bone pain, diarrhea and weight loss. More serious musculoskeletal issues also are possible.
Odomzo is marketed by Novartis, based in East Hanover, N.J.
The FDA has more about this approval.