FDA approves repotrectinib for patients with advanced ROS-1 fusion non-small cell lung cancer

The good news
The US Food and Drug Administration (FDA) approved repotrectinib (Augtyro^TM) for the treatment of patients with advanced ROS-1 fusion non-small cell lung cancer (NSCLC) in November of 2023. The approval was based on findings from the TRIDENT-1 trial, published on January 11, 2024 in The New England Journal of Medicine. The first author of the paper is former LCRF grantee, Alexander Drilon, MD, from Memorial Sloan Kettering Cancer Center (MSKCC.)

Why it’s important
Repotrectinib was evaluated in the TRIDENT-1 trial. 79% of patients who had not received prior treatment for their cancer responded to the drug. The control of the cancer lasted close to 3 years. Repotrectinib was especially effective in patients whose cancer spread to the brain.

What it means for patients
Patients with ROS-1 positive lung cancer have a new, effective treatment option. Since ROS-1 fusions are rare, it is very important that patients with newly diagnosed advanced NSCLC have molecular testing done on their cancer to provide appropriate treatment. If a patient has the ROS-1 fusion, they should discuss treatment options along with the associated risks and benefits with their Oncologists.

What to watch for
Repotrectinib is a new treatment option but unfortunately it is not a cure for these NSCLC patients. In the future we will see more studies evaluating why cancers develop resistance and how we can overcome it. There will also be further drug development to improve on currently available treatments.