FDA Approves Zidesamtinib for Previously Treated ROS1-Positive Non-Small Cell Lung Cancer
Clinical Summary:
-
The FDA approved zidesamtinib (Jideytro; GSK) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have received a prior ROS1 kinase inhibitor based on findings from the phase 1/2 ARROS-1 trial.
-
Among 117 previously treated patients, zidesamtinib achieved an objective response rate of 44%, with durable responses observed at 6 and 12 months. Clinical activity was also demonstrated in patients with brain metastases and ROS1 resistance mutations.
-
This approval introduces a next-generation ROS1-selective tyrosine kinase inhibitor designed to address acquired resistance and central nervous system disease, expanding treatment options for patients with previously treated ROS1-positive NSCLC.
The US Food and Drug Administration (FDA) approved zidesamtinib (Jideytro; GSK) for the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have received a prior ROS1 kinase inhibitor. The approval was supported by findings from the global phase 1/2 ARROS-1 trial.
"Despite advances in treatment, resistance mutations, disease progression in the brain, and treatment-related adverse events continue to create challenges for patients," stated Alexander Drilon, MD, Memorial Sloan Kettering Cancer Center, New York, New York. "The responses observed in ARROS-1, including in heavily pretreated patients, represent meaningful progress for people living with this disease."
ARROS-1 is an ongoing global phase 1/2 study evaluating zidesamtinib in patients with advanced ROS1-positive NSCLC and other ROS1-positive solid tumors. The FDA approval was based on efficacy data from 117 patients with locally advanced or metastatic ROS1-positive NSCLC who had previously received a ROS1 kinase inhibitor. The primary efficacy end points were objective response rate (ORR) and duration of response.
Among the efficacy population, the ORR was 44%. Estimated duration of response rates at 6 and 12 months were 82% and 69%, respectively. Clinical responses were observed in patients with brain metastases and tumors harboring ROS1 resistance mutations.
The pooled safety population included 446 patients treated with zidesamtinib. The most common adverse reactions occurring in at least 15% of patients were edema, peripheral neuropathy, constipation, fatigue, and dyspnea.
Zidesamtinib is a next-generation, ROS1-selective tyrosine kinase inhibitor designed to provide broad coverage of ROS1 resistance mutations while penetrating the blood-brain barrier to improve disease control in the central nervous system.
Zidesamtinib continues to be evaluated in the ARROS-1 trial, including as first-line therapy for patients with ROS1-positive NSCLC who have not previously received a ROS1 kinase inhibitor.
Source:
GSK. Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer. Accessed on July 22, 2026. 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/
