The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy.
The opinion was based on data from the phase II CheckMate -142 trial. The European Commission, which is authorized to approve medicines for the European Union, will now review the CHMP recommendation.
Opdivo and Yervoy are sponsored by Bristol Myers Squibb.
