Taletrectinib Approved for Locally Advanced and Metastatic NSCLC with ROS1 Rearrangements
On June 11, 2025, the US Food and Drug Administration (FDA) announced the approval of taletrectinib (Ibtrozi™) to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with ROS1 rearrangements. Taletrectinib is a next-generation, highly specific kinase inhibitor of ROS1 that was designed to treat ROS1+ NSCLC in patients whose tumors have developed drug resistance to previous targeted therapies as well as a first treatment option for newly diagnosed patients. The FDA approval is supported by data from two phase 2 clinical trials: TRUST-I and TRUST-II. Both