On July 22, 2026, the US Food and Drug Administration (FDA) announced the approval of zidesamtinib (Jideytro™) to treat patients with locally-advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
This approval is for patients who have been previously treated with ROS1-targeted tyrosine kinase inhibitors (TKIs).
Mutations in the ROS1 gene are responsible for approximately 2% of NSCLCs. And they are more common in younger patients (median age is 50 years), females, and never-smokers.
Zidesamtinib is a type of targeted therapy that is given as a daily pill. It is a tyrosine kinase inhibitor (TKI) that disrupts the activity of the mutated ROS1 protein to slow or stop cancer growth.
This FDA approval is supported by data from the ARROS-1 clinical trial that was conducted internationally. The trial studied 117 patients who were previously treated with one or more ROS1 targeted therapies. Data from the study showed 44% of patients had their tumors shrink or disappear with zidesamtinib treatment (overall response rate). In addition, 82% of patients responded to treatment for 6 months or longer (duration of response).
For more information, please see the FDA’s press release.