GSK Wins FDA Approval for Jideytro in ROS1-Positive NSCLC

GSK has received US Food and Drug Administration (FDA) approval for Jideytro (zidesamtinib), a selective ROS1 inhibitor for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have previously received a ROS1 kinase inhibitor.

The approval was granted ahead of the FDA’s original 18 September 2026 target action date and follows Breakthrough Therapy and Orphan Drug designations. 

Jideytro was developed by Nuvalent and became part of GSK’s oncology portfolio following its acquisition of the company.

The treatment is designed to address key challenges in ROS1-positive NSCLC, including resistance mutations, brain metastases and treatment tolerability. Its next-generation design provides selective ROS1 inhibition, broad coverage of resistance mutations and activity against cancer that has spread to the brain.

The approval is based on results from the global Phase I/II ARROS-1 trial. Among 117 previously treated patients, Jideytro achieved an objective response rate of 44%. 
The duration of response rates at six and 12 months were 82% and 69%, respectively.

Common adverse reactions included oedema, peripheral neuropathy, constipation, fatigue and dyspnoea.

Jideytro marks GSK’s first approved lung cancer medicine, strengthening its oncology portfolio and supporting the company’s expansion into targeted therapies for solid tumours.