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Ref Type
PMID
Authors
Title Jideytro (zidesamtinib) FDA Drug Label
Journal Vol Issue Date Pages Journal Short Title
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220185
Abstract Text

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Zidesamtinib Zidesamtinib 4 2
Drug Name Trade Name Synonyms Drug Classes Drug Description
Zidesamtinib Jideytro NVL-520|NUV 520|NUV520|NVL 520|NVL520|SIM18031A|NUV-520 ROS1 Inhibitor 23 Jideytro (zidesamtinib) is a brain-penetrant small-molecule inhibitor of ROS1, which potentially inhibits ROS1 kinase activity, decreases tumor cell viability, and reduces tumor growth (PMID: 40299789). Jideytro (zidesamtinib) is FDA-approved for use in patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer who have received prior ROS1 tyrosine kinase inhibitor (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ROS1 fusion lung non-small cell carcinoma predicted - 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...