25 February 2022 - Recommendation based on positive results from the Phase 3 CheckMate -648 trial, in which the combination demonstrated significantly improved overall survival compared to chemotherapy.
Bristol Myers Squibb today announced that the CHMP of the EMA has recommended approval of Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma with PD-L1 expression ≥ 1%.