Zidesamtinib approved for some patients with NSCLC

The FDA approved zidesamtinib (Jideytro, GSK) a ROS1-selective inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who previously received at least one ROS1 tyrosine kinase inhibitor (TKI). Zidesamtinib received FDA orphan drug designation.

Efficacy was evaluated in ARROS-1, a multicenter, single-arm, open-label, multi-cohort trial involving patients with previously treated locally advanced or metastatic ROS1-positive NSCLC. The efficacy population included 117 patients: 59 who had received one prior ROS1 TKI and 58 who had received two or more prior ROS1 TKIs.

The major efficacy outcome measures were confirmed overall response rate (ORR) and duration of response (DOR) according to RECIST v1.1, as assessed by blinded independent central review. In the overall efficacy population, the confirmed ORR was 44%. Among responders, 82% had a DOR of at least 6 months and 69% had a DOR of at least 12 months. ORR was 49% among patients who had received one prior ROS1 TKI and 38% among those who had received two or more prior ROS1 TKIs.

Zidesamtinib prescribing information includes warnings and precautions for central nervous system adverse reactions, QTc interval prolongation, interstitial lung disease/pneumonitis, skeletal fractures, myalgia with creatine phosphokinase elevation, pancreatic toxicity, and embryo-fetal toxicity.

The recommended zidesamtinib dose is 100mg taken orally once daily, with or without food, until disease progression or unacceptable toxicity.

Source: U.S. Food and Drug Administration. FDA approves zidesamtinib for ROS1-positive non-small cell lung cancer. July 22, 2026. Accessed July 27, 2026. 

GSK. Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer. Press release. GSK; July 22, 2026. Accessed August 13, 2026.