The U.S. Food and Drug Administration (FDA) has approved a new targeted treatment, zidesamtinib (brand name Jideytro), for adults with advanced ROS1-positive non–small cell lung cancer (NSCLC) whose cancer has already been treated with a ROS1 inhibitor.
ROS1-positive lung cancer is a rare type of NSCLC driven by a specific genetic change. While targeted therapies have improved outcomes, many patients eventually experience disease progression or develop resistance to earlier treatments. This new approval provides another option for patients whose cancer has stopped responding.
Jideytro (zidesamtinib) is a new targeted treatment approved by the FDA for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer who have already received a ROS1 kinase inhibitor. The approval was based on the ARROS-1 phase I/II study, which showed meaningful and durable responses, including in patients with brain metastases and ROS1 resistance mutations. In the overall study population, the objective response rate was 44%, with response duration rates of 82% at 6 months and 69% at 12 months.
Importantly, the treatment also showed activity in patients whose cancer had spread to the brain—a common and challenging aspect of ROS1-positive lung cancer. In this group, nearly half of patients experienced tumor shrinkage, and some had complete responses in the brain.
Like all cancer treatments, zidesamtinib can cause side effects. The most common include swelling (edema), nerve-related symptoms such as tingling or numbness (peripheral neuropathy), and constipation, fatigue, and shortness of breath. Serious side effects occurred in about 1 in 5 patients, so close monitoring by a healthcare team is important.
Experts say this approval represents meaningful progress, especially for patients who have already received multiple prior treatments. For many, the goal is not only to extend survival but also to maintain quality of life while living with cancer.
About Zidesamtinib
Jideytro (zidesamtinib) is a targeted oral cancer medicine approved for adults with advanced ROS1-positive non-small cell lung cancer whose disease has already been treated with a ROS1 kinase inhibitor. It is designed to block the ROS1 driver that helps cancer cells grow, and in the ARROS-1 study it showed responses in previously treated patients, including some with brain metastases and resistance mutations.
Patients should talk with their oncology team to understand whether zidesamtinib may be an appropriate option based on their individual treatment history and overall health.
Reference
- Jideytro US Prescribing Information
- https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026
