The FDA approved GSK’s Jideytro (zidesamtinib) for adults with previously treated ROS1-positive advanced NSCLC based on Phase I/II ARROS-1 trial results showing a 44% objective response rate and durable responses.
Written By: Nikita Jha, BPharm
Reviewed By: Pharmacally Editorial Team
The US Food and Drug Administration has approved Jideytro (zidesamtinib) 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, granted ahead of the FDA’s September 18, 2026 target action date, marks GSK’s first approved medicine for lung cancer and provides a new treatment option for patients whose disease has progressed after earlier ROS1-targeted therapy.
The decision is based on findings from the Phase I/II ARROS-1 trial (NCT05118789), which demonstrated durable antitumor activity in a heavily pretreated patient population, including individuals with brain metastases and tumors harboring ROS1 resistance mutations. Jideytro previously received both Breakthrough Therapy and Orphan Drug designations from the FDA.
Addressing Resistance in ROS1-Positive Lung Cancer
ROS1-positive NSCLC is a rare molecular subtype accounting for approximately 1% to 2% of NSCLC cases. It often affects younger adults with little or no smoking history and frequently spreads to the brain. Although currently available ROS1 inhibitors have improved outcomes, many patients eventually develop resistance mutations or experience disease progression within the central nervous system, creating a need for additional treatment options.
Jideytro is a next-generation selective ROS1 tyrosine kinase inhibitor developed to maintain activity against a broad range of ROS1 resistance mutations while penetrating the blood-brain barrier. The therapy entered GSK’s oncology pipeline through its acquisition of Nuvalent, strengthening the company’s portfolio of precision oncology medicines.
ARROS-1 Trial Demonstrated Durable Responses
The FDA approval was supported by data from 117 patients with advanced or metastatic ROS1-positive NSCLC previously treated with a ROS1 inhibitor in the global ARROS-1 Phase I/II study.
Among treated patients, Jideytro achieved an objective response rate (ORR) of 44% (95% CI: 34% to 53%). Responses also proved durable, with 82% of responders maintaining benefit at six months and 69% remaining in response at 12 months. Clinical activity was observed in patients with brain metastases and those carrying ROS1 resistance mutations, two groups that remain difficult to treat after progression on existing targeted therapies.
Across the pooled safety population of 446 patients, the most frequently reported adverse reactions were oedema, peripheral neuropathy, constipation, fatigue, and dyspnoea. The overall safety profile was considered consistent with continued clinical development.
Experts Highlight an Important New Treatment Option
Tony Wood, Chief Scientific Officer at GSK, said the rapid progression of Jideytro from clinical development to FDA approval reflects both the strength of the underlying science and the continuing need for more effective and better tolerated therapies for patients with ROS1-positive lung cancer.
ARROS-1 investigator Alexander Drilon, MD, Chief of the Early Development Service at Memorial Sloan Kettering Cancer Center, noted that resistance mutations, brain metastases, and treatment-related adverse events remain major clinical challenges. He said the durable responses observed in heavily pretreated patients represent meaningful progress for this population.
Patient advocate Janet Freeman-Daily, Co-Founder and President of The ROS1ders, emphasized that patients value therapies that not only extend survival but also allow them to maintain quality of life while remaining on treatment.
Future Development
Jideytro continues to be evaluated in the ongoing ARROS-1 study, including as a first-line treatment for patients with ROS1-positive NSCLC who have not previously received a ROS1 inhibitor.
The approval also expands GSK’s growing precision oncology portfolio following the Nuvalent acquisition. The company is awaiting an FDA decision on neladalkib (NVL-655) for ALK-altered NSCLC, expected by November 27, 2026, while continuing development of NVL-330 for HER2-altered NSCLC and risvutatug rezetecan (Ris-Rez) for small-cell lung cancer.
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About the Writer
Nikita Jha, BPharm (LinkedIn) a pharmacy graduate specializing in medical writing, with a strong ability to interpret complex medical and regulatory information and translate it into clear, accurate, and evidence-based healthcare content. Known for her attention to detail and precision, she focuses on delivering high-quality scientific communication that supports drug safety and informed decision-making.