Basal cell carcinoma accounts for about 80 percent of skin cancers that are not melanoma, a more deadly form of the disease.
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Although locally advanced basal skin cancer does not spread to other parts of the body, it cannot be cured with surgery or radiation therapy. Basal cell starts in the top layer of skin, usually in areas that are most exposed to the sun, the agency said Friday in a news release.
Odomzo is an oral, selective smoothened (SMO) inhibitor that regulates the hedgehog (Hh) signaling pathway, which is critical in stem cell maintenance and tissue fix. By suppressing this pathway, Odomzo may stop or reduce the growth of cancerous lesions.
Sonidegib was approved along with a Boxed Warning indicating that treatment with the drug may cause severe birth defects or the death of a developing fetus when administered to a pregnant woman.
The approval was based on demonstration of a durable objective response rate in an worldwide, multi-center, double-blind, randomized, two-arm, non-comparative trial in patients with locally advanced basal cell carcinoma not amenable to local therapy or metastatic basal cell carcinoma.
Seven of the 38 responding patients in the 200-mg cohort subsequently experienced disease progression, four of whom had maintained a response for 6 or more months.
Based on these data, the recommended dose and schedule for sonidegib is 200 mg once daily on an empty stomach, at least 1 hour prior to or 2 hours following a meal. Patients in the 200-mg group had an objective response rate of 58%, consisting of three (5%) complete responses and 35 (53%) partial responses.
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The most commonly encountered adverse events with the 200-mg dose of sonidegib were muscle spasms, alopecia, dysgeusia, nausea, musculoskeletal pain, diarrhea, decreased weight, decreased appetite, myalgia, abdominal pain, headache, vomiting, and pruritus. “The FDA approval of Odomzo offers a new and non-invasive treatment option for a potentially devastating disease that is hard to treat and can be disfiguring”, said Bruno Strigini, president, Novartis Oncology. Erivedge is marketed by Genentech in San Francisco, California. 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.
