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Therapy Name Zidesamtinib
Synonyms
Therapy Description

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).

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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).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ROS1 D2113G Advanced Solid Tumor sensitive Zidesamtinib Preclinical - Cell culture Actionable In a preclinical study, Jideytro (zidesamtinib) inhibited proliferation of transformed cells expressing ROS1 D2113G in culture (PMID: 37587872). 37587872
ROS1 fusion ROS1 G2032R lung non-small cell carcinoma predicted - sensitive Zidesamtinib Phase I Actionable In a Phase I trial (ARROS-1), Jideytro (zidesamtinib) treatment demonstrated safety and activity in patients with non-small cell lung cancer harboring a ROS1 fusion, including a response rate of 65% (11/17) with a median duration of response of 15.8 months in repotrectinib-naive patients and a response rate of 38% (3/8) in repotrectinib-pretreated patients harboring a ROS1 fusion and ROS1 G2032R (Ann Oncol (2024) 35 (Suppl_2): S804-S805; NCT05118789). detail...
ROS1 D2113N Advanced Solid Tumor sensitive Zidesamtinib Preclinical - Cell culture Actionable In a preclinical study, Jideytro (zidesamtinib) inhibited proliferation of transformed cells expressing ROS1 D2113N in culture (PMID: 37587872). 37587872
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...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT06797362 Expanded access Zidesamtinib Expanded Access Program of Zidesamtinib (NVL-520) for Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors Available USA | NLD | ITA | GBR | FRA | ESP | CAN | BEL | AUS 2
NCT05118789 Phase Ib/II Zidesamtinib A Study of NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1) Recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 4


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