Bristol-Myers Squibb Co.'s (BMY) melanoma drug has received FDA approval for yet another indication - this time as adjuvant therapy for fully resected stage III melanoma.
Yervoy, administered intravenously, was originally approved in 2011 to treat late-stage melanoma that cannot be removed by surgery. Today's approval of Yervoy extends its use to patients who are at high risk of developing recurrence of melanoma after surgery.
In a study, which compared patients who received Yervoy or a placebo as adjuvant therapy after complete surgical removal of melanoma, 49% of participants taking Yervoy had their cancer return after an average of 26 months while 62% of those receiving a placebo had their cancer return after an average of 17 months.
Early this month, Yervoy in combination with Bristol-Myers' another drug Opdivo received accelerated approval from the FDA for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. This is the first and only FDA approval of a Regimen of two Immuno-Oncology agents in cancer.
Yervoy is a monoclonal antibody that works by blocking CTLA-4, a molecule that may play a role in slowing down or turning off the body's immune system, and affects its ability to fight off cancerous cells.
Fatigue, diarrhea, itching, rash and nausea/vomiting are some of the common side effects associated with Yervoy while a serious, but uncommon side effect associated with the drug may be a fatal immune-mediated reaction.
Yervoy carries a black box warning of severe and fatal immune-mediated adverse reactions.
For the nine months ended September 30, 2015, Yervoy had worldwide sales of $861 million, down 9% from the year-ago period.
Now, with expanded FDA approvals will Yervoy get its mojo back? Stay tuned...
BMY closed Wednesday's trading at $67.59, up 1.18%.
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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.