FDA Approval Sought for Adjuvant Nivolumab for Completely Resected Stage IIB/C Melanoma
Source: Onc Live, February 2023
The FDA has accepted the supplemental biologics license application for nivolumab (Opdivo) as an adjuvant treatment for patients with completely resected stage IIB or IIC melanoma.
Additionally, the European Medicines Agency (EMA) has validated the type II variation marketing authorization application for nivolumab in the same indication.
The applications were supported by data from the phase 3 CheckMate76K trial (NCT04099251), which showed that nivolumab generated a statistically significant and clinically meaningful benefit in recurrence-free survival (RFS) compared with placebo, reducing the risk of recurrence or death by 58% (HR, 0.42; 95% CI, 0.30-0.59; P < .0001).2 At a prespecified interim analysis, patients treated with nivolumab experienced a 12-months RFS rate of 89% (95% CI, 86%-92%) compared with 79% (95% CI, 74%-84%) for those treated with placebo.