What are the new uses for drugs to treat melanoma

The U.S. Food and Drug Administration (FDA) announced Thursday that melanoma treatment drug Yervoy (ipilimumab) can now be used to reduce the risk of recurrence of deadly skin cancer after surgery.

The expanded use of the injection is as an adjuvant therapy for patients with stage 3 melanoma (cancer that has spread to 1 or more lymph nodes). Patients with this stage of melanoma typically have surgery to remove the melanin skin tumor and nearby lymph nodes, according to an FDA news release.

Melanoma is the most aggressive type of skin cancer and the leading cause of death from skin cancer.

"The FDA approved Yervoy for an additional use in patients who are at high risk for melanoma recurrence after surgery," Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation, said in a news release.

"The novel use of this drug for the early stages of melanoma builds on our understanding of how the immune system interacts with cancer," he added.

Yervoy was first approved by the FDA in 2011 for the treatment of advanced melanoma that cannot be removed surgically.

The new use of Yervoy was approved based on a study of 951 patients with stage 3 melanoma who had their tumors surgically removed. Forty-nine percent of patients taking Yervoy had their cancer recur, with an average time to recurrence of 26 months. Sixty-two percent of patients taking a placebo had their cancer recur, with an average time to recurrence of 17 months.

Yervoy helps the body's immune system recognize and attack melanoma cells, the FDA said.

Common side effects of Yervoy include rash, diarrhea, nausea, fatigue, itching, headache and weight loss. The drug can also cause autoimmune disorders of the digestive system, liver, skin, nervous system and hormone glands. The FDA said that because Yervoy can harm the fetus, it should not be taken by pregnant women.

Yervoy, manufactured by Bristol-Myers Squibb, carries a boxed warning and will include a medication guide informing patients of its potential serious side effects.

The National Cancer Institute estimates that approximately 74,000 new cases of melanoma are diagnosed in the United States each year, and nearly 10,000 people will die from the disease.