FDA Approves Jideytro (zidesamtinib) for ROS1-Positive NSCLC
July 27, 2026
Did you know? ROS1 is a gene found in healthy cells that plays an important role in cell growth and development. In some people, the ROS1 gene joins, or fuses, with another gene. This fusion can cause cells to grow out of control, which may lead to cancer. When this happens in the lung, it is called ROS1-positive non-small cell lung cancer (NSCLC), which occurs in about 2 out of every 100 cases (2%) of lung cancer.
On July 22, 2026, the U.S. Food and Drug Administration (FDA) granted accelerated approval for Jideytro (zidesamtinib) for people with locally advanced or metastatic ROS1-positive NSCLC whose cancer progressed after treatment with a ROS1 targeted therapy. ROS1 targeted therapies work by blocking the abnormal ROS1 protein that can help cancer cells grow.
This latest approval is based on the results of the ARROS-1 trial, which evaluated the safety and effectiveness of Jideytro (zidesamtinib) in people with locally advanced or metastatic ROS1-positive NSCLC who had previously received a ROS1-targeted therapy. The study showed that some participants experienced a response to treatment, and for those who responded, the benefits lasted for a meaningful period of time. It also showed promising results for people whose cancer had spread to the brain (brain metastases) or whose cancer had developed changes called resistance mutations that may cause a ROS1-targeted therapy to stop working.
This approval provides a new treatment option for people with ROS1-positive NSCLC whose cancer has progressed after a ROS1-targeted therapy, including people with brain metastases or resistance mutations.
Please speak with your healthcare team for more information about Jideytro (zidesamtinib) and to see if it may be an option for you. If you have questions about treatment, trials, or biomarker testing, contact our LungMATCH team at support@go2.org or 1-800-298-2436.
Read the full FDA announcement.