The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion regarding the approval of United States-based Bristol-Myers Squibb's Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) combination to include first-line treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma, it was reported on Friday.

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 three CheckMate -214 clinical trial, which was halted early following a planned interim analysis that showed the combination of Opdivo three mg/kg plus Yervoy one 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