Advanced Skin Cancer Treatment Approved

The US Food and Drug Administration recently approved sonidegib (Odomzo/Novartis) to treat patients suffering from locally advanced basal cell carcinoma — the most common form of advanced skin cancer – that had recurred post surgery or radiation therapy.

This therapy is specifically targeted for those basal cell carcinoma patients who are not candidates for surgery or radiation therapy.

Approval was based on results from a double-blind clinical trial involving 66 patients with locally advanced basal cell carcinoma who were randomly assigned to receive Odomzo 200 mg daily and 128 patients who were administered Odomzo 800 mg daily.

Study results indicated that 58% of patients given Odomzo 200 mg reported their tumors shrunk or disappeared — with the effect lasting approximately 1.9 to 18.6 months. Nearly half of the patients who responded found their tumor shrinkage to have lasted longer than six months.

While the response rates were similar in the Odomzo 800 mg daily patient group, there were also more frequent side effects. The most common adverse events were muscle spasms, alopecia, dysgeusia, fatigue, nausea, musculoskeletal pain, diarrhea, decreased weight, decreased appetite, myalgia, abdominal pain, headache, pain, vomiting, and pruritus.

Taken once daily, Odomzo works to inhibit the Hedgehog pathway to help reduce cancerous lesion growth.

Odomzo has a boxed warning indicating that treatment with the drug could potentially result in severe birth defects or the death of the developing fetus if taken during pregnancy.

Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, stated, “Thanks to a better understanding of the Hedgehog pathway, the FDA has now approved two drugs for the treatment of basal cell carcinoma just in the last three years.”

In 2012, the FDA approved Vismodegib (Erivedge/Genentech) to treat locally advanced and metastatic basal cell carcinoma.