WASHINGTON -- The combination of ipilimumab (Yervoy) and nivolumab (Opdivo) can be used to treat intermediate- to poor-risk patients with previously untreated renal cell carcinoma, the .
Approval was based on the Checkmate 214 trial, which found an 18-month overall survival rate of 75% with the combination, compared with 60% among patients treated with sunitinib (Sutent).
The trial was stopped early, in September 2017, when interim analysis identified a clear survival benefit with the combination.
"The recommended schedule and dose for this combination," the FDA said in announcing the approval, "is nivolumab, 3 mg/kg, followed by ipilimumab, 1 mg/kg, on the same day every 3 weeks for four doses, then nivolumab, 240 mg, every 2 weeks or 480 mg every 4 weeks."
Adverse effects include fatigue, rash, diarrhea, myalgia, arthralgia, pruritus, nausea, cough, pyrexia, and decreased appetite.
Both drugs are sold by Bristol-Myers Squibb. The combination had been designated as "breakthrough therapy" and underwent priority review.