Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer
Approval based on ARROS-1 phase I/II trial demonstrating meaningful and durable responses in patients with locally advanced or metastatic disease1 Next-generation design aims to address key efficacy and tolerability challenges of treating ROS1-positive NSCLC GSK's first approval in lung cancer, part of a growing portfolio of targeted treatments LONDON, July 22, 2026 /PRNewswire/ -- GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has approved Jideytro (zidesamtinib), a ROS1 selective inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor.1 The approval comes ahead of the original target action date of 18 September 2026 and follows the FDA's Breakthrough Therapy and Orphan Drug Designations.2 Jideytro, part of the portfolio from the recently completed acquisition of Nuvalent, Inc. 3, was developed to address key efficacy and/or tolerability challenges of treating ROS1-postive NSCLC. Its next-generation design aims to combine high target-selectivity, broad coverage of ROS1 resistance mutations and blood-brain barrier penetration to address disease in the brain.