SILVER SPRING, Md., July 24 (UPI) -- The Food and Drug Administration announced it approved the once-a-day pill Odomzo for patients with recurrent basal cell carcinoma or who can't have surgery or radiation therapy for the disease.
Skin cancer is the most common form of cancer, with roughly 3.5 million basal and squamous cancers being diagnosed each year in about 2.2 million people, according to the American Cancer Society. Basal cell carcinomas account for 80 percent of non-melanoma skin cancers.
Basal cell carcinoma starts in the top layer of the skin, developing in areas that have been exposed to a lot of sun or other forms of ultraviolet radiation. Locally advanced basal cell skin cancer are types that have not spread to other parts of the body but can't be treated with surgery or radiation.
"Our increasing understanding of molecular pathways involved in cancer has led to approvals of many oncology drugs in difficult-to-treat diseases for which few therapeutic options previously existed," said Dr. Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, in a press release. "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."
Odomzo works by blocking the Hedgehog pathway, which basal cell cancers use to transmit information during cell development, which stops or reduces the growth of tumors.
In a clinical trial, 66 patients with locally advanced basal cell carcinoma were randomly given a 200 mg daily dose of Odomzo and 128 patients received an 800 mg dose each day. The group that received a 200 mg dose saw 58 percent of participants' tumors shrink or disappear, with the effect lasting at least 1.9 to 18.6 months. The 800 mg group saw similar results, however an increase of side effects was seen with the higher dosage.
"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 of Novartis, which developed the drug, in a press release.
