Regeneron Receives FDA Approval for Fianlimab Plus Cemiplimab in Advanced Melanoma

Regeneron today announced that the FDA has approved fianlimab plus cemiplimab (Libtayo) for the treatment of adults with previously untreated unresectable or metastatic melanoma. In the Phase 3 RELATIVITY-020 trial, fianlimab plus cemiplimab demonstrated a statistically significant improvement in progression-free survival compared to pembrolizumab. Fianlimab is an anti-LAG-3 antibody that, when combined with anti-PD-1 cemiplimab, provides dual checkpoint blockade. This approval establishes fianlimab plus cemiplimab as a new standard of care in first-line advanced melanoma.