FDA Approves Expanded Use for Melanoma Drug
Yervoy can now be used after surgery to reduce risk of skin cancer returning
THURSDAY, Oct. 29, 2015 (HealthDay News) -- The melanoma drug Yervoy (ipilimumab) can now be used to reduce the risk of the recurrence after surgery, the U.S. Food and Drug Administration said Thursday.
The expanded use of this intravenous drug is an adjunct therapy for patients with stage III melanoma. The "approval of Yervoy extends its use to patients who are at high risk of developing recurrence of melanoma after surgery," Richard Pazdur, M.D., director of the FDA's Office of Hematology and Oncology Products at the Center for Drug Evaluation and Research, said in an FDA news release.
Yervoy was first approved by the FDA in 2011 to treat late-stage melanoma that cannot be removed with surgery. The expanded approval is based on a study of 951 patients with stage III melanoma who had their cancer removed during surgery. The cancer returned an average of 26 months after surgery in 49 percent of patients who took Yervoy, compared with 62 percent of those given a placebo. The cancer returned within 17 months, on average, among those who took a placebo.
Common side effects of Yervoy included rash, diarrhea, nausea, fatigue, itching, headache, and weight loss. The drug can also cause autoimmune disease in the digestive system, liver, skin, nervous system, and hormone-producing glands. Pregnant women should not take Yervoy because it can harm the fetus, the FDA said. Yervoy, made by Bristol-Myers Squibb, carries a boxed warning and will include a medication guide to inform patients about potentially severe side effects.