Arvin Yang, MD, PhD
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of nivolumab (Opdivo) as an adjuvant treatment for adult patients with completely resected melanoma with lymph node involvement or metastatic disease, according to Bristol-Myers Squibb, the developer of the PD-1 inhibitor.
The recommendation is based on findings from the phase III CheckMate-238 trial, in which the recurrence-free survival (RFS) rate at 18 months with nivolumab was 66.4% (95% CI, 61.8%-70.6%) compared with 52.7% (95% CI, 47.8%-57.4%) for ipilimumab (Yervoy) in patients with stage IIIB/C or IV melanoma. There was a 35% reduction in the risk of recurrence or death with the PD-1 inhibitor versus the CTLA-4 inhibitor (HR, 0.65; 95% CI, 0.53-0.80; P
The European Commission (EC) will now review the CHMP recommendation and make a final decision on whether to approve nivolumab for this indication in the European Union.
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