FDA Approves Odomzo (Sonidegib) for Basal Cell Skin Cancer

The US Food and Drug administration (FDA) has approved Odomzo (sonidegib) for certain people with basal cell carcinoma, the most common type of skin cancer. The drug is for locally advanced basal cell carcinoma that can’t be cured with surgery or radiation. Sometimes this is because the cancer has come back after surgery or radiation was tried.

Odomzo is a pill taken once a day. It targets something called the Hedgehog pathway, a process that is important in growth and development in many of the body’s cells. In basal cell carcinoma, the process is often abnormal. This is the second drug of its type approved by the FDA. The first, Erivedge (vismodegib), was approved in 2012 to treat both locally advanced and metastatic basal cell carcinoma.

The FDA based its approval on a clinical trial of 194 people with locally advanced basal cell carcinoma who took Odomzo. More than half the participants saw their tumors shrink or disappear. For about half of these patients, the tumor shrinkage lasted for 6 months or longer.

The most common side effects were muscle spasms, hair loss, taste changes, fatigue, nausea and vomiting, pain, diarrhea, weight loss, poor appetite, and itching. Less common, but more severe side effects included muscle damage. The drug carries a boxed warning, which is the FDA’s strictest warning for drugs that have serious side effects. Odomzo may cause death or severe birth defects in a developing fetus if taken by a pregnant woman.

Odomzo is marketed by Novartis Pharmaceuticals Corporation.

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