FDA Approves Zidesamtinib in Pretreated ROS1+ NSCLC

The FDA has approved zidesamtinib (Jideytro) for the treatment of patients with locally advanced or metastatic ROS1-positive non–small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor, according to a press release from the developer, GSK.¹

The agent previously received the breakthrough therapy and orphan drug designations from the FDA. Additionally, the FDA accepted the filing of a new drug application for the agent in locally advanced or metastatic ROS1-positive NSCLC in November 2025.²

Zidesamtinib was evaluated in patients with advanced ROS1-positive NSCLC and other solid tumors in the single-arm phase 1/2 ARROS-1 trial (NCT05118789). Among all 177 patients with NSCLC enrolled, the objective response rate (ORR) was 44% (95% CI, 34%-53%), and the 6- and 12-month duration of response (DOR) rates were 82% and 69%, respectively.

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

Patients in the trial received zidesamtinib at 100 mg once daily as an oral tablet.³ Eligible patients in cohorts 2a, 2b, 2c, and 2d of the trial had histologically or cytologically confirmed locally advanced or metastatic NSCLC harboring a ROS1 rearrangement; they also had prior anticancer treatment, measurable disease per RECIST v1.1, and adequate baseline organ function.

Regarding safety, the most common adverse events in the pooled safety population (n = 446) were edema, peripheral neuropathy, constipation, fatigue, and dyspnea, all of which occurred in at least 15% of patients.

References

1. Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer. News release. GSK. July 22, 2026. Accessed July 22, 2026. https://tinyurl.com/mryktyyj
2. Nuvalent announces FDA acceptance of new drug application for zidesamtinib for the treatment of TKI pre-treated patients with advanced ROS1-positive NSCLC. News release. Nuvalent. November 19, 2025. Accessed July 22, 2026. https://tinyurl.com/3xz63b8v
3. A study of zidesamtinib (NVL-520) in patients with advanced NSCLC and other solid tumors harboring ROS1 rearrangement (ARROS-1). ClinicalTrials.gov. Updated October 24, 2025. Accessed July 22, 2026. https://tinyurl.com/4ezpp3z8