Yervoy Gets a New Use

Yervoy (ipilimumab), from Bristol-Myers Squibb, approved to reduce risk of melanoma returning after surgery

/ Author:  / Reviewed by: Beth Bolt, RPh

(RxWiki News) A medication previously approved to treat melanoma that cannot be removed by surgery just got the approval it needed for another melanoma-related use.

That use is reducing the risk that melanoma will return after surgery, and the medication is Yervoy (ipilimumab). The Bristol-Myers Squibb drug received US Food and Drug Administration (FDA) approval for this new use on Wednesday.

“Today’s approval of Yervoy extends its use to patients who are at high risk of developing recurrence of melanoma after surgery,” said Richard Pazdur, MD, director of the FDA's Office of Hematology and Oncology Products, in a press release. “This new use of the drug in earlier stages of the disease builds on our understanding of the immune system’s interaction with cancer.”

Yervoy is an injected drug that blocks a molecule in the body that is thought to reduce the body's ability to fight off cancer. When patients who have melanoma (the deadliest form of skin cancer) receive Yervoy, their immune systems may be more likely to "recognize, target and attack cells in melanoma tumors," according to the FDA.

Patients with advanced melanoma often undergo surgery to remove the lesions caused by the disease, but there's always a risk that the cancer will return. The FDA approved Yervoy's new use because it appeared to extend "recurrence-free survival," or the amount of time it took the melanoma to return after surgery.

A study of 951 patients measured recurrence-free survival and overall survival. It found that 49 percent of melanoma patients who received Yervoy after surgery had their cancer come back after an average of 26 months. Sixty-two percent of the patients receiving a placebo (fake treatment) saw their cancer return in 17 months on average.

Patients in this study reported side effects that included headache, weight loss, rash, fatigue and diarrhea, among others. This drug also poses a risk of autoimmune disease in various parts of the body, which is why it carries a boxed warning. Pregnant women shouldn't take Yervoy.

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Review Date: 
October 29, 2015
Last Updated:
November 3, 2015