ODOMZO

By Gary M. White, MD


Caution: Facts about drugs changes frequently. The latest research, package insert and FDA information should be consulted before prescribing.

Chemical Name

Sonidegib

Indication

Treat patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy.

Mechanism of Action

Odomzo works by inhibiting a molecular pathway, called the Hedgehog pathway, which is active in basal cell cancers.

Black Boxed Warning

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.

Dosing

200 mg daily

Efficacy

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.

Side Effects

The most common side effects of Odomzo were muscle spasms, alopecia, dysgeusia, fatigue, nausea, musculoskeletal pain, diarrhea, decreased weight, decreased appetite, myalgia, abdominal pain, headache, pain, vomiting and pruritus. Odomzo also has the potential to cause serious musculoskeletal-related side effects, including increased serum creatine kinase levels with rare reports of rhabdomyolysis, muscle spasms, and myalgia.

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