The U.S. Food and Drug Administration (FDA) has officially approved a drug called “Odomzo” (generically known as sonidegib) to treat a recurring form of skin cancer. According to a statement released by the FDA, the drug is now approved for treating “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.”
Odomzo works by suppressing the molecular pathway that’s active when the body is inflicted with basal cell cancers. In a clinical study, 66 patients were treated with 200 mg a day of Odomzo, while 128 patients took a daily dose of 800 mg.
Researchers found that the drug had the ability to shrink or destroy the cancerous tumor in more than half (58%) of the patients who were taking 200 mg. Furthermore, the effects of the drug lasted anywhere between 1.9 months and one-and-half years—approximately half the patients experienced the effects for at least six months.
Similar results were seen in the patients who took the higher dose; however, these individuals also experienced more side effects, which are said to include muscle spasms, distorted sense of taste, hair loss, fatigue, nausea, headaches, abdominal and musculoskeletal pain, vomiting and weight loss, diarrhea, appetite loss, and itching. The FDA also warns that the drug may not be safe for pregnant women, as it can potentially be dangerous for the fetus.
This is the second drug that the FDA has approved in the past three years to treat basal cell carcinoma. (The drug “Erivedge” was approved in 2012.) Skin cancer continues to be the most common form of cancer among Americans. The majority of skin cancer cases are non-melanoma cancers—basal cell carcinoma accounts for 80% of non-melanoma cancer cases.
Sources for Today’s Article:
“FDA approves new treatment for most common form of advanced skin cancer,” U.S. Food and Drug Administration web site, July 24, 2015; http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455862.htm.