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

The U.S. FDA accepted Nuvation Bio's NDA for taletrectinib, a ROS1 TKI for advanced ROS1+ NSCLC, for Priority Review, with a PDUFA goal date of June 23, 2025. The NDA is based on Phase 2 TRUST-I and TRUST-II studies showing durable responses and prolonged PFS in ROS1+ NSCLC patients. Taletrectinib could be a best-in-class treatment option for this patient population.