GSK's Jideytro (zidesamtinib) approved in US for ROS1‑positive NSCLC

Regulatory approval

The US Food and Drug Administration approved Jideytro (zidesamtinib) for adult patients with locally advanced or metastatic ROS1‑positive non‑small cell lung cancer who received a prior ROS1 kinase inhibitor. The approval followed the FDA's Breakthrough Therapy and Orphan Drug designations and arrived ahead of the original target action date of 18 September 2026.

Clinical evidence

The decision was based on the global single‑arm ARROS‑1 phase I/II trial. In 117 patients with ROS1‑positive NSCLC previously treated with a ROS1 inhibitor, the objective response rate was 44% (95% CI: 34–53%). Duration of response rates at six and 12 months were 82% and 69%, respectively. Responses were observed in patients with brain metastases and those harbouring ROS1 resistance mutations.

Safety

In the pooled safety population (n=446) the most common adverse reactions (≥15%) were oedema, peripheral neuropathy, constipation, fatigue and dyspnoea.

Product profile and company context

Jideytro is a ROS1‑selective kinase inhibitor designed for high target selectivity, broad coverage of ROS1 resistance mutations and blood–brain barrier penetration. The medicine is part of GSK's lung cancer portfolio following its acquisition of Nuvalent and represents GSK's first approved lung cancer treatment. GSK is advancing other Nuvalent‑derived investigational NSCLC agents, including neladalkib (NVL‑655), which has an FDA target decision date of 27 November 2026, and NVL‑330.