08/18/2026
FDA Approves New Drug to Treat Non-Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) has approved a new drug for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least one prior ROS1 tyrosine kinase inhibitor (TKI). Zidesamtinib (Jideytro) is a kinase inhibitor administered as an oral tablet.
The safety and efficacy of zidesamtinib (Jideytro) were evaluated in a multicenter, single-arm, open-label, multi-cohort trial of 117 patients with previously treated locally advanced or metastatic ROS1-positive NSCLC. 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 (BICR).
Warnings and precautions for zidesamtinib (Jideytro) include 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 most common adverse reactions (≥15%) for zidesamtinib (Jideytro) include edema, peripheral neuropathy, constipation, fatigue, and dyspnea. The most common Grade 3 or 4 laboratory abnormalities (≥2%) include increased CPK, increased triglycerides, decreased lymphocytes, and decreased hemoglobin.
View the FDA’s announcement here:
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zidesamtinib-ros1-positive-non-small-cell-lung-cancer