FDA approves GSK's Jideytro for NSCLC

On July 22, 2026, GSK plc announced that the US United States — Food and Drug Administration (FDA) 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 have received a prior ROS1 kinase inhibitor. The approval came ahead of the original target action date of September 18, 2026, and followed the FDA's Breakthrough Therapy and Orphan Drug Designations. Jideytro was part of the portfolio from GSK's recently completed acquisition of Nuvalent Inc., Inc. The approval was based on results from the global single-arm ARROS-1 phase I/II clinical trial, which demonstrated meaningful and durable responses, including in patients with brain metastases and ROS1 resistance mutations. In the overall population (n=117), the objective response rate (ORR) was 44%, and duration of response (DOR) rates at six and 12 months were 82% and 69%, respectively. Jideytro is GSK's first approved medicine in lung cancer. The company is also advancing other medicines from the Nuvalent Inc. acquisition, including neladalkib for ALK-altered NSCLC and NVL-330 for HER2-altered NSCLC, as well as risvutatug rezetecan from licensor Grand Pharmaceutical Group Inc.