FDA Approves Zidesamtinib for Pretreated ROS1-Positive NSCLC

The US Food and Drug Administration (FDA) has granted approval for zidesamtinib (Jideytro), a next-generation ROS1-selective inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

This indication specifically applies to patients who have previously received at least one ROS1 kinase inhibitor. The approval arrived nearly two months ahead of the original target action date of Sept. 18, 2026, following the drug’s prior designations as both a Breakthrough Therapy and an Orphan Drug.

Advancing the treatment paradigm in ROS1-positive NSCLC

ROS1-positive NSCLC represents a distinct subset of lung cancer, often affecting approximately 50,000 individuals worldwide annually. Notably, this driver mutation frequently appears in younger patients in their 40s and 50s who have little to no smoking history.

For oncology nurses, managing this population requires a focus on long-term treatment tolerability, as these patients may remain on therapy for several years.

Zidesamtinib was specifically engineered to overcome the efficacy and tolerability limitations associated with first-generation ROS1 inhibitors. Its next-generation design focuses on three clinical priorities: high target-selectivity, broad coverage of ROS1 resistance mutations, and blood-brain barrier penetration to address central nervous system (CNS) metastases.

Clinical evidence: The ARROS-1 trial

The FDA’s decision was supported by data from the ARROS-1 phase I/II clinical trial, a global study evaluating zidesamtinib in patients with advanced ROS1-positive solid tumors. The efficacy analysis focused on 117 patients with NSCLC who had progressed following prior ROS1 inhibitor therapy.

The trial demonstrated meaningful and durable clinical responses, even in heavily pre-treated individuals. Key efficacy findings included:

• An objective response rate (ORR) of 44% (95% CI: 34-53%) in the overall pre-treated population.
• Durable responses, with duration of response (DOR) rates of 82% at six months and 69% at 12 months.
• Observed activity in patients harboring ROS1 resistance mutations and those with brain metastases.

Alexander Drilon, MD, ARROS-1 trial investigator and Chief of the Early Development Service at Memorial Sloan Kettering Cancer Center, noted in a news release that these responses represent significant progress for a patient population that frequently faces disease progression in the brain and the emergence of resistance.

Nursing considerations: Safety and monitoring

Oncology nurses play a critical role in monitoring the safety profile of new targeted therapies. In the pooled safety population of 446 patients, the most common adverse reactions (occurring in ≥15% of patients) were:

• Edema
• Peripheral neuropathy
• Constipation
• Fatigue
• Dyspnoea

Nurses should educate patients on recognizing signs of peripheral neuropathy and managing edema, which are common with kinase inhibitors of this class. The goal, as highlighted by patient advocates, is to maintain a high quality of life while on treatment.

Janet Freeman-Daily, co-founder of The ROS1ders, emphasized in the news release that for this community, the approval provides an essential new option that balances effectiveness with a tolerable profile.

For the oncology nursing community, this approval introduces a potent tool for managing a challenging disease state, providing patients with a chance for prolonged disease control.

Reference

GSK. Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer. Published July 22, 2026. Accessed July 23, 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/