U.S. Food and Drug Administration Accepts for Priority Review Nuvation Bio's New ... - BioSpace

Nuvation Bio's NDA for taletrectinib, a next-gen ROS1 TKI for advanced ROS1+ NSCLC, has been accepted by the FDA with a PDUFA goal date of June 23, 2025. Taletrectinib, supported by Phase 2 TRUST studies, shows potential as a best-in-class treatment with durable responses and prolonged PFS.