Bristol-Myers Squibb's Opdivo in combination with low-dose Yervoy approved in Europe for first-line advanced RCC

Bristol-Myers Squibb on Monday said that the European Commission cleared Opdivo (nivolumab) in combination with low-dose Yervoy (ipilimumab) for use in the first-line setting in patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC). Chief commercial officer Chris Boerner remarked "we are extremely pleased that the European Commission has approved Opdivo plus low-dose Yervoy based on the significant survival benefit demonstrated in the CheckMate -214 trial."

The CheckMate -214 study compared the efficacy of Opdivo plus low-dose Yervoy versus Pfizer's Sutent (sunitinib) in patients with previously untreated advanced RCC. The late-stage study was stopped early after the combination regimen demonstrated superior overall survival versus Sutent monotherapy.  

Commenting on clearance of the therapy in first-line advanced RCC, Bristol-Myers Squibb remarked "this decision represents the first approval of an immuno-oncology (I-O) combination therapy for patients with this type of cancer in the European Union." 

For related analysis, see Physician Views Poll Results: European oncologists say Opdivo/Yervoy practice changing in RCC, but may have limited window of opportunity

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