USFDA approves Novatis's Odomzo for advanced skin cancer

Odomzo carries a Boxed Warning alerting healthcare professionals that Odomzo may cause death or severe birth defects in a developing fetus when administered to a pregnant woman. Pregnancy status should be verified prior to the start of Odomzo treatment, and both male and female patients should be warned about these risks and advised to use effective contraception.

The efficacy of Odomzo was established in a multi-center, double-blind clinical trial, in which 66 patients with locally advanced basal cell carcinoma were randomly assigned to receive Odomzo 200 mg daily and 128 patients were assigned to receive Odomzo 800 mg daily. The study’s primary endpoint was objective response rate, which is the percentage of patients who experienced partial shrinkage or complete disappearance of their tumor(s). Results showed that 58 percent of patients treated with Odomzo 200 mg had their tumors shrink or disappear. This effect lasted at least 1.9 to 18.6 months, and approximately half of the responding patients’ tumor shrinkage lasted six months or longer. Response rates were similar in patients who received Odomzo 800 mg daily, however side effects were more common at this dose.

At a dose of 200 mg daily, the most common side effects of Odomzo were muscle spasms, alopecia (hair loss), dysgeusia (distortion in the sense of taste), fatigue, nausea, musculoskeletal pain, diarrhea, decreased weight, decreased appetite, myalgia (muscle pain), abdominal pain, headache, pain, vomiting and pruritus (itching). Odomzo also has the potential to cause serious musculoskeletal-related side effects, including increased serum creatine kinase levels [with rare reports of muscle tissue breakdown (rhabdomyolysis)], muscle spasms, and myalgia.

Odomzo is marketed by East Hanover, New Jersey-based Novartis Pharmaceuticals Corporation. Erivedge is marketed by Genentech in San Francisco, California.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.