07:22 AM EST, 12/23/2024 (MT Newswires) -- Bristol-Myers Squibb ( BMY ) said Monday that the European Commission has approved Opdivo in combination with Yervoy as a first-line treatment for adult patients with microsatellite instability-high or mismatch repair deficient unresectable or metastatic colorectal cancer.

The company said the approval was based on the results of a phase 3 trial where the combination therapy demonstrated "statistically significant" improvement in the dual primary endpoint of progression-free survival and reduced the risk of disease progression or death.

The combination therapy's safety profile also remained consistent with previous data, without new safety signals identified, the company added.

Bristol-Myers Squibb ( BMY ) said the approval covers all 27 member states of the European Union, along with Iceland, Liechtenstein and Norway.