FDA Approves Nivolumab for Completely Resected Stage IIB/C Melanoma

Source: Dermatology Times, October 2023

Approval is based on data from Bristol Myers Squibb’s CheckMate – 76K trial.

Today, the US Food and Drug Administration (FDA) approved Bristol Myers Squibb’s nivolumab (Opdivo) as monotherapy in the adjuvant setting for the treatment of patients with completely resected stage IIB or IIC melanoma. The FDA’s approval is based on results from the pivotal phase 3 CheckMate -76K trial, where nivolumab demonstrated a statistically significant and clinically meaningful benefit in recurrence-free survival (RFS) versus placebo. Additionally, the safety profile of nivolumab was consistent with previously reported studies.

“Hopefully nivolumab will help patients live longer with less chance for recurrence. With an overall good safety profile, our patients can live longer with an improved quality of life,” Aaron Farberg, MD, double board-certified dermatologist, Mohs surgeon, and the chief medical officer at Bare Dermatology in Dallas, Texas, told Dermatology Times.
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