Did FDA approve zidesamtinib for pretreated ROS1-positive NSCLC patients?

Yes. On July 22, 2026, the FDA approved zidesamtinib (Jideytro) for adults with locally advanced or metastatic ROS1-positive NSCLC after at least one prior ROS1 tyrosine kinase inhibitor. The approval was based on the ARROS-1 trial, which showed a 44% confirmed overall response rate and was cleared two months ahead of the FDA goal date.