OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of...for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.

Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) as a monotherapy for the adjuvant treatment of adults and adolescents 12 years of age and older with stage IIB or IIC melanoma who have undergone complete resection, based upon results from the CheckMate -76K trial....The EC’s decision is based on results from the Phase 3 CheckMate -76K trial, in which, with a minimum follow-up of 7.8 months, Opdivo reduced the risk of recurrence or death in patients with stage IIB or IIC melanoma by 58% versus placebo (hazard ratio [HR] 0.42; 95% CI: 0.30-0.59; p<0.0001).

OPDIVO as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults....OPDIVO as monotherapy is indicated for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

OPDIVO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of...patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection, in the adjuvant setting.

Nivolumab is recommended, within its marketing authorisation, as an option for the adjuvant treatment of completely resected melanoma in adults with lymph node involvement or metastatic disease.

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....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, Opdivo reduced the risk of recurrence or death by 58% versus placebo...

This multicentre, double-blind, randomised, controlled, phase 3 trial was done in 130 academic centres, community hospitals, and cancer centres across 25 countries….4-year overall survival was 77·9% (95% CI 73·7-81·5) with nivolumab and 76·6% (72·2-80·3) with ipilimumab (HR 0·87 [95% CI 0·66-1·14]; p=0·31)....At a minimum of 4 years' follow-up, nivolumab demonstrated sustained recurrence-free survival benefit versus ipilimumab in resected stage IIIB-C or IV melanoma indicating a long-term treatment benefit with nivolumab.