FDA expands indication of Yervoy (ipilimumab) in metastatic melanoma- BMS

The FDA has expanded the approved use of Yervoy (ipilimumab), from BMS, to include a new use as adjuvant therapy for patients with stage III melanoma, to lower the risk that the melanoma will return following surgery. Ipilimumab, administered intravenously, was originally approved in 2011 to treat late-stage melanoma that cannot be removed by surgery.

The safety and effectiveness of ipilimumab for this new use were studied in 951 patients who received ipilimumab or a placebo as adjuvant therapy following complete surgical removal of melanoma. The study measured the recurrence-free survival time and overall survival. Forty-nine percent of participants taking ipilimumab had their cancer return, after an average progression-free period of 26 months, compared to 62% of those receiving a placebo, whose cancer returned after an average of 17 months progression-free. The analysis of overall survival data has not yet occurred. The most common side effects of ipilimumab in this study were rash, diarrhea, fatigue, itching, headache, weight loss and nausea.