FDA approves supplemental NDA for IBTROZI® (taletrectinib) for the treatment of locally advanced or metastatic ROS1+ NSCLC

“This approval is a significant milestone for IBTROZI because this data is now part of the FDA-approved label, something physicians and patients can turn to directly,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “A median duration of response of more than four years—the longest median DOR reported for an FDA-approved ROS1 TKI—is a remarkable outcome for people living with ROS1+ NSCLC, and having it in the label means something real for patients: a clearer sense of how long they might expect to stay on treatment, and more confidence in what that path could look like at a moment when a new diagnosis can feel overwhelming. It also gives physicians additional evidence to support using IBTROZI early in a patient’s care, when that choice matters most.”