20 November 2018 - - The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending approval of the Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) combination to include first-line treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma, US-based Bristol-Myers Squibb Company (NYSE: BMY) said.

This recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.

The CHMP recommendation is based on positive data from the Phase 3 CheckMate -214 clinical trial, which was stopped early following a planned interim analysis that showed the combination of Opdivo 3 mg/kg plus Yervoy 1 mg/kg demonstrated a significant increase in overall survival with a 37% decreased risk of death in intermediate- and poor-risk patients, regardless of PD-L1 expression level, compared to a current standard of care, sunitinib (Hazard Ratio [HR] 0.63; 99.8% Confidence Interval [CI]: 0.44 to 0.89; p