FDA Approves Adjuvant Ipilimumab for Stage 3 Melanoma
The FDA has approved ipilimumab (Yervoy) for adjuvant treatment of stage 3 cutaneous melanoma after complete resection.
The U.S. Food and Drug Administration (FDA) has approved ipilimumab (Yervoy) for the adjuvant treatment of patients with stage 3 cutaneous melanoma who have undergone complete resection, including total lymphadenectomy, to reduce the risk that the melanoma will return after surgery, according to an FDA press release.1
“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 Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research.
“This new use of the drug in earlier stages of the disease builds on our understanding of the immune system's interaction with cancer.”
The recommended dose and schedule for adjuvant ipilimumab is 10 mg/kg administered intravenously over 90 minutes every 3 weeks for 3 doses, then 10 mg/kg every 12 weeks for up to 3 years.
Approval for the new use was based on a double-blind, randomized, placebo-controlled study that compared ipilimumab with placebo as adjuvant therapy following complete surgical resection of melanoma in 951 patients with resected stage 3A, 3B, and 3C cutaneous melanoma. Results showed that relapse-free survival was 26 months in the ipilimumab group and 17 months in the placebo arm (HR, 0.75; 95% CI, 0.64 - 0.900; P < .002).
In regard to safety, the most common adverse events associated with ipilimumab treatment were rash, pruritus, diarrhea, nausea, colitis, vomiting, weight loss, fatigue, pyrexia, headache, decreased appetite, and insomnia. In addition, 41% of ipilimumab-treated patients experienced grade 3 to 5 immune-mediated adverse reactions. If a patient experiences toxicity, doses of ipilimumab should be omitted rather than delayed.
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Health care providers should be aware that ipilimumab has the potential to cause severe and fatal immune-mediated adverse reactions.
Ipilimumab is already approved by the FDA for the treatment of unresectable or metastatic melanoma.
- FDA approves Yervoy to reduce the risk of melanoma returning after surgery [news release]. Bethesda, MD: U.S. Food and Drug Administration; October 28, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncPressA/ucm469944.htm. Accessed October 29, 2015.