LONDON, United Kingdom, July 23, 2026
GSK plc has announced that the U.S. Food and Drug Administration (FDA) has approved Jideytro (zidesamtinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have previously received a ROS1 kinase inhibitor. The approval, granted ahead of the original September 18, 2026 PDUFA target date, follows the therapy’s Breakthrough Therapy and Orphan Drug Designations, marking an important regulatory milestone for GSK’s first approved lung cancer medicine. The approval is supported by data from the global ARROS-1 Phase I/II clinical trial, where Jideytro demonstrated meaningful and durable clinical responses, including activity in patients with brain metastases and ROS1 resistance mutations. The next-generation ROS1-selective inhibitor is designed to overcome key treatment limitations by combining broad mutation coverage, high target selectivity, and central nervous system penetration, providing a promising new option for patients with advanced ROS1-positive lung cancer.
ARROS-1 Trial Demonstrates Durable Clinical Benefit
The FDA approval is based on results from the global ARROS-1 Phase I/II study, which evaluated Jideytro (zidesamtinib) in 117 patients with advanced or metastatic ROS1-positive NSCLC who had previously been treated with a ROS1 inhibitor. The trial achieved an objective response rate (ORR) of 44%, with responses proving durable over time. Duration of response (DOR) reached 82% at six months and 69% at twelve months, highlighting sustained anti-tumor activity even in heavily pre-treated patients. Importantly, the therapy also demonstrated efficacy in individuals whose disease had spread to the brain and in patients harboring ROS1 resistance mutations, addressing major clinical challenges associated with disease progression. The encouraging efficacy profile reinforces the therapeutic potential of next-generation targeted kinase inhibitors designed specifically for resistant ROS1-driven lung cancers.
Next-Generation Design Targets Resistance and Brain Metastases
Jideytro was engineered to overcome the limitations of earlier ROS1-targeted therapies by offering high target selectivity, broad activity against multiple ROS1 resistance mutations, and effective penetration of the blood-brain barrier. These characteristics are particularly important because ROS1-positive NSCLC frequently metastasizes to the central nervous system, making durable intracranial disease control a critical treatment objective. The safety profile remained manageable, with the most frequently reported adverse reactions including oedema, peripheral neuropathy, constipation, fatigue, and dyspnoea. By balancing efficacy with tolerability, Jideytro aims to extend disease control while allowing patients to maintain quality of life during long-term treatment. The approval represents a significant advance for an estimated 50,000 patients diagnosed globally each year with ROS1-positive NSCLC, a disease that commonly affects younger non-smokers.
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FDA Approval Expands GSK’s Precision Oncology Portfolio
The approval of Jideytro marks an important milestone in GSK’s expanding oncology strategy, following the recent acquisition of Nuvalent, the biotechnology company that originally developed zidesamtinib. The medicine becomes GSK’s first approved therapy for lung cancer, strengthening the company’s growing portfolio of precision oncology treatments targeting genetically defined tumors. GSK continues to advance several additional targeted therapies, including neladalkib for ALK-altered NSCLC, currently under FDA review, as well as NVL-330 for HER2-altered NSCLC and other late-stage oncology programs. The approval of Jideytro reinforces the growing role of molecularly targeted therapies in transforming lung cancer treatment by delivering more personalized options for patients with specific genomic alterations while addressing resistance mechanisms that limit the effectiveness of earlier targeted medicines.
Source: GSK Press release
