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May 27, 2021Yervoy Receives Expanded Melanoma Indication for Adults
May 27, 2021 – The U.S. FDA has approved an expanded indication for Yervoy (ipilimumab), manufactured by Bristol Myers Squibb, to be used in combination with nivolumab to treat unresectable or metastatic melanoma in adults. Yervoy is already approved as a monotherapy for this indication in adults and in children who are at least 12 years old.
An estimated 106,110 new cases of melanoma are expected to be diagnosed in the United States in 2021, and 7,180 people are projected to die of the disease. While it is less common than other forms of skin cancer, it is often deadly when it’s reached an advanced stage.
In a clinical trial, treatment with Yervoy and nivolumab delivered statistically significant improvements in overall survival and progression-free survival compared to patients treated with Yervoy alone.
Recommended dosing under the expanded indication is 3mg/kg of the patient’s body weight administered via 90-minute intravenous infusion once every three weeks, with nivolumab 1mg/kg given as a 30-minute intravenous infusion on the same day. Yervoy is given with nivolumab for a maximum of four doses or until unacceptable toxicity, whichever occurs first. Following four doses of combination therapy, nivolumab is administered as a single agent until disease progression or unacceptable toxicity occur.
Originally FDA approved in 2011, Yervoy is also indicated to treat renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, and malignant pleural mesothelioma.