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Molecular Profile ROS1 fusion
Therapy Zidesamtinib
Indication/Tumor Type lung non-small cell carcinoma
Response Type sensitive

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ROS1 fusion lung non-small cell carcinoma sensitive Zidesamtinib FDA approved Actionable In a Phase I trial (ARROS-1) that supported FDA approval, Jideytro (zidesamtinib) treatment demonstrated safety and activity in patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer who have received prior ROS1 TKI, resulting in an overall response rate (ORR) of 44% (51/117), duration of response rate of 84% at 6 mo, 78% at 12 mo, and 62% at 18 mo, with respective progression-free survival rate of 57%, 48%, and 40% (J Thor Oncol (2025) 20 (10, Suppl_1): S3; NCT05118789). detail... detail...
ROS1 fusion lung non-small cell carcinoma sensitive Zidesamtinib Guideline Actionable Jideytro (zidesamtinib) is included in guidelines as subsequent therapy (category 2A) for patients with advanced or metastatic non-small lung cancer harboring a ROS1 fusion (NCCN.org). detail...
PubMed Id Reference Title Details
NCCN.org Full reference...
Jideytro (zidesamtinib) FDA Drug Label Full reference...
PL02.15 Pivotal ARROS-1 Efficacy and Safety Data: Zidesamtinib in TKI Pre-treated Patients with Advanced/Metastatic ROS1+ NSCLC Full reference...