FDA grants Fast Track to Moderna's mRNA-4359 with pembrolizumab for PD-L1-positive melanoma

The FDA granted Fast Track designation to mRNA-4359 combined with Merck's pembrolizumab for checkpoint-inhibitor-refractory, unresectable or metastatic melanoma with PD-L1 positive tumors. Fast Track allows more frequent FDA contact and a rolling submission. The company presented first-line Phase 2 expansion data at the AACR meeting on April 20, 2026.

• Fast Track designation for mRNA-4359 plus pembrolizumab
• Population: checkpoint-inhibitor-refractory, unresectable or metastatic melanoma
• PD-L1 positive tumors, TPS above 1%
• First-line Phase 2 expansion data presented at AACR on April 20, 2026