The Food and Drug Administration has approved a new drug to treat the most common form of skin cancer, marking the first time the agency has signed off on a drug for metastatic basal cell carcinoma.
The drug, known as Erivedge, was approved under the FDA’s expedited 6-month review program, which is used to advance priority treatments as quickly as possible
According to the agency, which noted the approval in a press release issued Monday morning, basal cell carcinoma is a common, slow-growing and painless form of cancer that starts on the outer layer of the skin, usually in areas most often exposed to sunlight or other forms of ultraviolet radiation.
Apparently, Erivedge taken in pill form once a day blocks or inhibits the molecular pathway that is most active in the development of skin cancers.
“Our understanding of molecular pathways involved in cancer has enabled the development of targeted drugs for specific diseases,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This approach is becoming more common and will potentially allow cancer drugs to be developed more quickly. This is important for patients who will have access to more effective therapies with potentially fewer side effects.”
According to the FDA statement, Erivedge was evaluated in a single study of 96 patients with locally advanced or metastatic basal cell carcinoma. The study found that in the metastatic patients who received the drug, 30 percent experienced partial shrinkage in the their cancers, while 43 percent of those with a locally advanced disease experienced either a complete disappearance or partial shrinkage.
Some common side effects were also noted in the study, however, including muscle spasms, nausea, diarrhea, weight loss, hair loss, and decreased appetite.
Genentech, part of the Roche Group, markets Erivedge.