On Nov. 16, 2023, the U.S. Food and Drug Administration (FDA) approved Augtyro (repotrectinib) for people living with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a ROS1 gene mutation.

The approval was based on results from the TRIDENT-1 study, which evaluated the use of Augtyro (repotrectinib) as a first- or second-line therapy in people with locally advanced or metastatic ROS1-positive NSCLC. People receiving Augtyro (repotrectinib) for first-line treatment showed a significant response rate and a prolonged duration of response when receiving the therapy. Similarly, those given Augtyro (repotrectinib) after receiving a previous ROS1-targeted therapy without chemotherapy also experienced a meaningful response rate and duration of response in response to the therapy.

Additionally, it has previously been shown that one of the challenges of ROS1-positive NSCLC can be treating disease that has spread to the brain. Results from the study also showed that in those with confirmed brain metastases prior to starting treatment, Augtyro (repotrectinib) had a measurable reduction of the brain metastases for both individuals receiving first- and second-line therapy

The announcement offers a new treatment option for people with locally advanced or metastatic ROS1-positive NSCLC. ROS1 mutations are rare in NSCLC, affecting 1-2% of people with lung cancer, and are more common in persons who are young, female, and those with little to no smoking history.

Read the full announcement from the FDA here.