14 January 2019 - Approval based on results from Phase 3 CheckMate-214 trial.
Bristol-Myers Squibb today announced that 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.