FDA approves Jideytro (zidesamtinib) for previously treated ROS1 – positive non-small cell lung cancer – GSK
GSK plc announced the FDA has approved Jideytro (zidesamtinib), a ROS1 selective inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor. The approval comes ahead of the original target action date of 18 September 2026 and follows the FDA’s Breakthrough Therapy and Orphan Drug Designations.
Jideytro, part of the portfolio from the recently completed acquisition of Nuvalent, Inc., was developed to address key efficacy and/or tolerability challenges of treating ROS1-postive NSCLC. Its next-generation design aims to combine high target-selectivity, broad coverage of ROS1 resistance mutations and blood-brain barrier penetration to address disease in the brain. Approximately 50,000 people worldwide are diagnosed each year with ROS1-positive NSCLC, often non-smokers in their 40s and 50s who could stay on treatment for several years.
Tony Wood, Chief Scientific Officer, GSK, said: “The rapid progression of Jideytro from development to approval reflects both the strength of the underlying science and the urgent need for additional effective and tolerable treatments for ROS1-positive lung cancer. Today’s approval provides an important new option for these patients and supports our strategy to acquire assets with validated targets that could meaningfully improve standards of care.”
The approval of Jideytro is based on results from the global single-arm ARROS-1 phase I/II clinical trial in patients with advanced or metastatic ROS1-positive NSCLC previously treated with a ROS1 inhibitor. The study demonstrated meaningful and durable responses, including in patients with brain metastases and ROS1 resistance mutations. In the overall population (n=117), the objective response rate (ORR) was 44% (95% confidence interval [CI]: 34-53%). Duration of response (DOR) rates at six and 12 months were 82% and 69%, respectively.
The most common (≥15%) adverse reactions in the pooled safety population (n=446) included: oedema, peripheral neuropathy, constipation, fatigue and dyspnoea.
Alexander Drilon, MD, ARROS-1 trial investigator and Chief of the Early Development Service at Memorial Sloan Kettering Cancer Center, 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.”
Janet Freeman-Daily, Co-Founder and President of The ROS1ders, said: “For patients, the goal is not just more time, but quality time to live life as normally as possible while on treatment. The ROS1-positive community is deeply invested in advancing care with treatments that are effective and tolerable. Today’s approval gives patients and their doctors an important new option and represents meaningful progress for our community.”
Jideytro is GSK’s first approved medicine in lung cancer. The company is advancing additional medicines from the recent Nuvalent acquisition, including neladalkib (NVL-655) for patients with ALK-altered NSCLC, which is currently under FDA review with a target decision date of 27 November 2026, and NVL-330, an investigational treatment for HER2-altered NSCLC. GSK is also advancing risvutatug rezetecan (Ris-Rez), a B7-H3-targeted antibody-drug conjugate in late-stage development with recently reported positive Phase III data in relapsed small-cell lung cancer from licensor Hansoh Pharma Inc.
About the ARROS-1 trial
ARROS-1 (NCT05118789) is a global phase I/II trial evaluating zidesamtinib in patients with advanced ROS1 positive NSCLC and other ROS1-positive solid tumours. The FDA approval is based on results from 117 patients with ROS1-positive NSCLC previously treated with a ROS1 inhibitor. Zidesamtinib continues to be studied in ARROS-1, including in first-line treatment for patients who have not previously received a ROS1 inhibitor.
