GSK plc (NYSE: GSK) announced on July 22, 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 (NSCLC) who have previously received a ROS1 kinase inhibitor.

The approval came ahead of the original target action date of September 18, 2026. The drug had previously received FDA Breakthrough Therapy and Orphan Drug Designations. Jideytro is GSK's first approved medicine in lung cancer and was part of the company's recently completed acquisition of Nuvalent, Inc.

The approval is based on results from the global single-arm ARROS-1 phase I/II clinical trial involving 117 patients with ROS1-positive NSCLC previously treated with a ROS1 inhibitor. The study showed an objective response rate of 44% (95% CI: 34–53%). Duration of response rates at six and 12 months were 82% and 69%, respectively. The most common adverse reactions in the pooled safety population (n=446) included edema, peripheral neuropathy, constipation, fatigue, and dyspnea.

Approximately 50,000 people worldwide are diagnosed annually with ROS1-positive NSCLC, according to the company's press release.

Alexander Drilon, MD, chief of the Early Development Service at Memorial Sloan Kettering Cancer Center and an ARROS-1 trial investigator, said: "Despite advances in treatment, resistance mutations, disease progression in the brain and treatment-related adverse events continue to create challenges for patients. The responses observed in ARROS-1, including in heavily pre-treated patients, represent meaningful progress for people living with this disease." Dr. Drilon has served as a consultant to and/or received expense reimbursements from Nuvalent, Inc.

GSK is also advancing neladalkib (NVL-655) for ALK-altered NSCLC, currently under FDA review with a target decision date of November 27, 2026, and NVL-330, an investigational treatment for HER2-altered NSCLC.