Jideytro (Zidesamtinib) - (ARROS-1)

July 22, 2026: GSK plc (LSE/NYSE: GSK) announced the FDA approved Jideytro (zidesamtinib), a ROS1-selective inhibitor, for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who previously received a ROS1 kinase inhibitor. The approval came ahead of the original target action date of September 18, 2026 and follows FDA Breakthrough Therapy and Orphan Drug designations.

Approval was based on the global single-arm ARROS-1 Phase I/II trial in previously treated ROS1-positive NSCLC. In the overall population (n=117), objective response rate was 44% (95% CI: 34–53%); duration-of-response rates at 6 and 12 months were 82% and 69%, respectively. Responses were observed including in patients with brain metastases and ROS1 resistance mutations. In the pooled safety population (n=446), common (≥15%) adverse reactions were oedema, peripheral neuropathy, constipation, fatigue, and dyspnoea.

GSK noted Jideytro is its first approved lung cancer medicine and was part of the recently completed acquisition of Nuvalent. Upcoming/other catalysts mentioned: neladalkib (NVL-655) for ALK-altered NSCLC is under FDA review with a target decision date of November 27, 2026; NVL-330 is in development for HER2-altered NSCLC.