Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) as a monotherapy for the adjuvant treatment of adults and adolescents 12 years of age and older with completely resected stage IIB or IIC melanoma.

If approved, Opdivo would become the only PD-1 inhibitor that - between two approvals* - is indicated as an adjuvant treatment for patients within stages IIB, IIC, III, as well as stage IV resected melanoma. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.

“Many patients with stage IIB or stage IIC melanoma face the difficult reality of disease recurrence within five years of surgery,” said Gina Fusaro, Ph.D., vice president, global program lead, Bristol Myers Squibb. “In the data from the CheckMate -76K trial, Opdivo was shown to significantly reduce the risk of disease recurrence for these patients. The CHMP’s recommendation brings us closer to potentially providing Opdivo for use in treating additional earlier stages of melanoma in the adjuvant setting, addressing an unmet need for patients in the EU.”

The positive opinion is based upon safety and efficacy results from the Phase 3 CheckMate -76K trial, in which, with a minimum follow-up of 7.8 months, Opdivoreduced the risk of recurrence or death by 58% versus placebo (hazard ratio [HR] 0.42; 95% CI 0.30-0.59; p < 0.0001).The safety profile of Opdivo was consistent with previously reported studies.