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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