FDA approves Jideytro, next-generation ROS1 inhibitor for previously treated NSCLC

Patients with ROS1-positive non-small cell lung cancer (NSCLC) often respond well to targeted therapy initially, but many eventually develop resistance or experience progression in the brain. FDA has approved Jideytro (zidesamtinib) for adults with locally advanced or metastatic ROS1-positive NSCLC whose disease has progressed after treatment with a prior ROS1 kinase inhibitor, providing a new option for this difficult-to-treat setting.

Zidesamtinib is distinct from earlier ROS1 inhibitors because it was designed to maintain activity against a broad range of ROS1 resistance mutations while selectively targeting ROS1, potentially improving tolerability. It also penetrates the blood-brain barrier, an important feature because central nervous system metastases are common in patients with ROS1-positive NSCLC.

The approval was based on the phase 1/2 ARROS-1 trial, which enrolled 117 patients with advanced ROS1-positive NSCLC previously treated with a ROS1 inhibitor. The objective response rate was 44%, with 82% of responses maintained at 6 months and 69% at 12 months. Responses were observed in patients with brain metastases and in those whose tumors harbored ROS1 resistance mutations.

The most common adverse reactions, occurring in at least 15% of patients, were edema, peripheral neuropathy, constipation, fatigue, and dyspnea.

"Despite advances in treatment, resistance mutations, disease progression in the brain and treatment-related adverse events continue to create challenges for patients. The responses observed in ARROS-1, including in heavily pre-treated patients, represent meaningful progress for people living with this disease," said Alexander Drilon, MD, ARROS-1 trial investigator and Chief of the Early Drug Development Service at Memorial Sloan Kettering Cancer Center.

Source: GSK. (2026 Jul 22). Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer