Did you know? ROS1 is a gene found in cells that is important for cell growth and survival. In some people, the ROS1 gene begins to mutate or change and may fuse or join with another gene. When this happens, it can be a driving cause of cancer. When changes in the ROS1 gene cause lung cancer, it’s called ROS1-positive lung cancer. ROS1-positive lung cancer occurs in about 2 out of every 100 cases (2%) of lung cancer. 

On June 11, 2025, the U.S. Food and Drug Administration (FDA) announced the approval of Ibtrozi (taletrectinib) for people with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). 

This latest approval is based on the results of the TRUST-I and TRUST-II studies, which looked at how safe and effective Ibtrozi (taletrectinib) is for people with ROS1-positive NSCLC who had previously received either no prior ROS1-targeted therapy or just 1, and who may also have received chemotherapy. The study showed a promising response rate and responses that lasted a meaningful amount of time in people who had previously received ROS1-targeted therapy, and results were even more promising for people who had not previously received ROS1-targeted therapy. This is encouraging news for a rare and aggressive form of lung cancer with limited treatment options. 

Ibtrozi (taletrectinib) is a type of treatment known as a tyrosine kinase inhibitor (TKI), which works by blocking the altered ROS1 gene caused by the mutation and can help to slow down or stop the growth of cancer cells. 

Please speak with your healthcare team for more information about Ibtrozi (taletrectinib) and see if it may be a good 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.