The U.S. Food and Drug Administration has expanded the approved use of Yervoy (ipilimumab) to now include treatment as an adjuvant therapy for patients with stage III melanoma to lower the risk of melanoma returning following surgery. Yervoy is a monoclonal antibody that blocks cytotoxic T-lymphocyte antigen (CTLA-4), which may play a role in slowing down or turning off the body's immune system, and affects its ability to fight off cancerous cells.
"The approval of Yervoy extends its use to patients who are at high risk of developing recurrence of melanoma after surgery," Richard Pazdur, MD, Director of the FDA's Office of Hematology and Oncology Products, said in a news 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 has previously been approved to treat late-stage melanoma that cannot be removed by surgery (OT 4/25/11 issue).
Safety and Effectiveness
Safety and effectiveness for Yervoy for this newly approved use were evaluated in a study of 951 patients who received Yervoy or a placebo as adjuvant therapy following complete surgical removal of melanoma. Forty-nine percent of patients taking Yervoy had their cancer return after an average of 26 months, compared with 62 percent of patients of the patients taking the placebo who had their cancers return after an average of 17 months. Analysis of the overall survival data is not yet available.
The most common side effects for the patients taking Yervoy in this study were rash, diarrhea, fatigue, itching, headache, weight loss, and nausea. Yervoy can also cause autoimmune disease in the digestive system, liver, skin, nervous system, and hormone-producing glands. Yervoy should not be taken by women who are pregnant because the drug may cause harm to a developing fetus.
'Powerful New Tool'
"This approval means stage III melanoma patients have a powerful new tool to help prevent their disease from progressing," Tim Turnham, PhD, Executive Director of the Melanoma Research Foundation, said in a statement.
"The standard of care following the initial surgery treatment [for these patients] has been to remain under close observation by their physicians, rather than seek active treatment. This approval marks the first new FDA approved adjuvant option in 20 years."
Boxed Warning
Due to the potential for fatal immune-mediated adverse reactions and unusual severe side effects with Yervoy, the label includes a Boxed Warning. A Medication Guide will also be provided to patients to inform them about the therapy's potential side effects, according to an FDA news release.
Yervoy is manufactured by Bristol-Myers Squibb.
Clinical Quick Facts: Yervoy
Drug: Yervoy (ipilimumab)
Approved Indication: Treatment as an adjuvant therapy for patients with stage III melanoma to lower the risk of melanoma returning following surgery
Serious Side Effects: Autoimmune disease in the digestive system, liver, skin, nervous system, and hormone-producing glands
Common Side Effects: Rash, diarrhea, fatigue, itching, headache, weight loss, and nausea