On July 22, 2026, the FDA approved zidesamtinib (Jideytro) for adults with locally advanced or metastatic ROS1-positive non–small cell lung cancer (NSCLC) who have received at least 1 prior ROS1 tyrosine kinase inhibitor (TKI). The approval was based on the ARROS-1 trial, a multicenter, open-label, single-arm study of 117 patients with previously treated ROS1-positive NSCLC. Among the overall efficacy population, the confirmed overall response rate was 44%, with 82% having a duration of response of at least 6 months and 69% at least 12 months.
In patients who had received 1 prior ROS1 TKI, the response rate was 49%, compared with 38% in those who had received 2 or more prior ROS1 TKIs. The recommended dose is 100 mg orally once daily, with or without food, until disease progression or unacceptable toxicity. The prescribing information includes warnings for central nervous system adverse reactions, QTc prolongation, interstitial lung disease/pneumonitis, skeletal fractures, myalgia with creatine phosphokinase elevation, pancreatic toxicity, and embryo-fetal toxicity. The FDA approved the application 2 months ahead of the goal date using the Real-Time Oncology Review pilot program and Assessment Aid.
Source
- US Food and Drug Administration. FDA approves zidesamtinib for ROS1-positive non–small cell lung cancer. Accessed July 27, 2026. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zidesamtinib-ros1-positive-non-small-cell-lung-cancer