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FDA Approves Sonidegib for Some Patients with Advanced Basal Cell Carcinoma

September 2, 2015, by NCI Staff

Illustration of the epidermis.

The outer skin layer (epidermis) includes several cell types, including basal cell keratinocytes, the source cells for BCC.

Credit: Terese Winslow

On July 24, the Food and Drug Administration (FDA) approved sonidegib (Odomzo®) to treat some patients with basal cell carcinoma (BCC), the most common form of non-melanoma skin cancer.

The approval is for patients with a rare type of BCC that has become locally advanced because it has returned after prior surgery or radiation or whose cancer is not amenable to surgery or radiation.

There are about 3 million new cases of BCC annually in the United States. Almost all of these are treated surgically, and some are treated with radiation. However, for some rare cases, where the disease is locally advanced or spreads to distant sites, these treatments may not be options.

"Locally advanced BCC may not be detected until it has deeply invaded the skin, and in some of these cases surgery and radiation are not options," explained John DiGiovanna, M.D., of the Dermatology Branch in NCI's Center for Cancer Research. "This kind of BCC can be disfiguring or even life threatening, so having an additional drug treatment may be an advantage."

The FDA approval of sonidegib was based on results from an ongoing multi-center clinical trial in which patients with advanced tumors were randomly assigned to receive sonidegib daily at one of two doses, 200 mg or 800 mg.

Tumor reductions occurred in 38 (58 percent) of 66 patients with locally advanced BCC treated with the lower dose, three of which were complete responses. Responses lasted for at least 6 months in nearly 50 percent of these patients. The response rates were similar in those who received the higher dose, but patients treated with this dose had worse side effects. The FDA approval is for the 200 mg dose.

Approximately one-third of patients in the trial halted treatment because of side effects. Among its side effects, sonidegib can cause adverse musculoskeletal-related reactions, and the drug's label also includes a boxed warning that the drug may cause death or severe birth defects in a developing fetus in pregnant woman.

Sonidegib joins vismodegib (Erivedge®), which was approved by the FDA in January 2012, to treat locally advanced and metastatic BCC. Both drugs inhibit the Hedgehog signaling pathway, overactivation of which is linked to BCC development.

"The mainstay of treatment for locally advanced BCC continues to be early diagnosis and surgical removal," Dr. DiGiovanna said. "However, for patients who are not candidates for surgery or radiation, drugs such as vismodegib and sonidegib offer new treatment options."

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