FDA Approves Zidesamtinib (Jideytro) for Previously Treated ROS1-Positive Non-Small Cell Lung Cancer

On July 22, 2026, the U.S. Food and Drug Administration (FDA) approved zidesamtinib (Jideytro, GSK) for locally advanced or metastatic non-small cell lung cancer (NSCLC) with a ROS1 mutation previously treated with another ROS1 inhibitor.

Worldwide, 2.1 million people are diagnosed with NSCLC every year. About 50,000 of them will have a genetic change called ROS1 rearrangement. ROS1-positive NSCLC is an aggressive form of lung cancer. It often spreads to the brain and bones. It is more common in: 

• Younger patients. The median age of ROS1-positive NSCLC is 50.5, compared to 70 for all types of lung cancer.

• Women. Of all people with ROS1-positive NSCLC, 64.5% are women. 

• Non-smokers. 

• People without other lung cancer biomarkers.

In a GSK press release about the approval, Dr. Alexander Drilon of Memorial Sloan Kettering Cancer Center said, “Despite advances in treatment, resistance mutations, disease progression in the brain, and treatment-related adverse events continue to create challenges for [ROS1-positive] patients.” 

How does zidesamtinib treat ROS1-positive NSCLC?

Zidesamtinib is a type of targeted therapy called a tyrosine kinase inhibitor (TKI). It targets ROS1 fusions, which help cancer cells grow.

Zidesamtinib is approved for adult patients with locally advanced or metastatic ROS1-positive NSCLC who have received a prior ROS1 kinase inhibitor. Other TKIs approved to treat ROS1-positive NSCLC include crizotinib (multiple brand names), entrectinib (Rozlytrek), repotrectinib (Augtyro), and taletrectinib (Ibtrozi).

Zidesamtinib is a daily oral medication that is taken until the cancer progresses or side effects are not tolerable.

ARROS-1: The study that led to zidesamtinib approval

The approval for zidesamtinib was based on the results from the phase 1/2 ARROS-1 clinical trial. The study included 117 people with ROS1-positive NSCLC that had been previously treated with a ROS1 inhibitor. The trial included patients with brain metastases and ROS1 rearrangements that are resistant to treatment.

The objective response rate (ORR) was 44%. This is the percentage of people in the clinical trial whose cancer shrinks after taking the medication. At 6 months, the duration of response (DOR) was 82%. At 12 months, the DOR was 69%. DOR is the percentage of patients whose cancer is still controlled by the treatment.

“The responses observed in ARROS-1, including in heavily pre-treated patients, represent meaningful progress for people living with this disease,” said Dr. Drilon. 

What are the common side effects of zidesamtinib?

The most common side effects of zidesamtinib during the ARROS-1 clinical trial were: 

• Edema (swelling)

• Peripheral neuropathy

• Constipation

• Fatigue

• Dyspnea (shortness of breath)

Next steps for people living with ROS1-positive NSCLC

If you or a loved one has ROS1-positive NSCLC, ask your healthcare team about how your current treatment is working for you and if zidesamtinib or ongoing clinical trials may be right for you. 

“For patients, the goal is not just more time, but quality time to live life as normally as possible on treatment. The ROS1-positive community is deeply invested in advancing care with treatments that are effective and tolerable. Today’s approval gives patients and their doctors an important new option and represents meaningful progress for our community,” said Janet Freeman-Daily, co-founder and president of The ROS1ders, a patient advocacy group for ROS1-positive NSCLC, in a GSK press release about the approval.

Questions to ask your care team about zidesamtinib

Consider asking your care team the following questions about zidesamtinib: 

• Do I have ROS1-positive NSCLC?

• What ROS1 inhibitors are available to me?

• Is zidesamtinib an option for my care?

• Are there side effects I need to be concerned about?

Sources:

• GSK. Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer. https://www.gsk.com/en-gb/media/press-releases/jideytro-zidesamtinib-approved-in-the-us-for-previously-treated-ros1-positive-non-small-cell-lung-cancer/?linkId=100000431854785

• CA: A Cancer Journal for Clinicians. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21834

• ClincalTrials.gov. A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1). https://clinicaltrials.gov/study/NCT05118789

• Lung Cancer Foundation of America. ROS1. https://lcfamerica.org/about-lung-cancer/diagnosis/biomarkers/ros1/