15 January 2019 - - The European Commission has approved the combination of Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg ("low-dose") for the first-line treatment of patients with intermediate- and poor-risk advanced renal cell carcinoma. This decision represents the first approval of an Immuno-Oncology combination therapy for patients with this type of cancer in the European Union, US-based Bristol-Myers Squibb Company (NYSE: BMY) said.

The approval is based on results from the Phase 3 CheckMate -214 clinical trial, which was stopped early following a planned interim analysis that showed that the combination of Opdivo plus low-dose Yervoy demonstrated a significant increase in overall survival, with a 37% decreased risk of death in intermediate- and poor-risk patients compared to a current standard of care, sunitinib (Hazard Ratio [HR] 0.63; 99.8% Confidence Interval [CI]: 0.44 to 0.89; p