GSK wins US approval for Jideytro in previously treated ROS1-positive lung cancer

GSK announced on 22 July 2026 that the US Food and Drug Administration approved Jideytro (zidesamtinib), a ROS1 selective inhibitor, for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer who had already received a prior ROS1 kinase inhibitor¹. The decision arrived early: the approval came ahead of the original target action date of 18 September 2026 and followed the FDA's Breakthrough Therapy and Orphan Drug Designations¹.

The drug's design targets known weaknesses in earlier ROS1 therapies. According to GSK, the molecule was built to combine high target selectivity, broad coverage of ROS1 resistance mutations, and the ability to cross the blood-brain barrier to treat disease that has spread to the brain¹.

Approval rested on the ARROS-1 phase I/II study. The single-arm trial enrolled patients with advanced or metastatic ROS1-positive NSCLC who had already been treated with a ROS1 inhibitor, and the company said it showed meaningful and durable responses, including in patients with brain metastases and resistance mutations¹. In the efficacy population, the objective response rate among 117 patients was 44% (95% CI: 34-53%), with duration of response rates of 82% at six months and 69% at 12 months¹. Safety data came from a larger pooled group, where the most common adverse reactions occurring in 15% or more of 446 patients included oedema, peripheral neuropathy, constipation, fatigue and dyspnoea¹.

GSK noted Jideytro is its first approved medicine in lung cancer¹. The drug came through the company's recently completed acquisition of Nuvalent, Inc.¹ Other assets from that deal remain in development: GSK said it is progressing neladalkib (NVL-655) for ALK-altered NSCLC, now under FDA review with a target decision date of 27 November 2026, along with NVL-330, an investigational treatment for HER2-altered NSCLC¹.