Bristol Myers announces CHMP opinion recommending Opdivo combination approval

Bristol Myers (BMY) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Opdivo, in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo as monotherapy as adjuvant treatment after surgical resection for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumors have PD-L1 expression 1%. The CHMP adopted an opinion based on results from the CheckMate -77T trial, in which the perioperative regimen of neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo monotherapy demonstrated statistically significant and clinically meaningful improvement in event-free survival, the study’s primary endpoint. The European Commission, which has the authority to approve medicines for the European Union, will now review the CHMP recommendation.