Zidesamtinib
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| Trade names | Jideytro |
| Other names | NUV-520; NVL-520 |
| AHFS/Drugs.com | jideytro |
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| Routes of administration | By mouth |
| Drug class | Tyrosine kinase inhibitor |
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| Formula | C22H22FN7O |
| Molar mass | 419.464 g·mol−1 |
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Zidesamtinib, sold under the brand name Jideytro, is an anti-cancer medication used for the treatment of non-small cell lung cancer.[1] Zidesamtinib is a kinase inhibitor.[1] It is taken by mouth.[1]
Zidesamtinib was approved for medical use in the United States in July 2026.[2]
Medical uses
[edit]Zidesamtinib is indicated for the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer who have received a prior ROS1 kinase inhibitor.[1]
Adverse effects
[edit]The US prescription label 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.[2]
Mechanism of action
[edit]Zidesamtinib is a kinase inhibitor that works by blocking ROS1, an abnormal protein that drives some lung cancers to grow, including forms that have become resistant to earlier ROS1 treatments.[3] Zidesamtinib also works on the related protein ALK.[1] In laboratory and animal studies, zidesamtinib stopped cancer cells with ROS1 changes from growing and slowed tumor growth, including tumors in the brain.[4]
History
[edit]Efficacy was evaluated in ARROS-1 (NCT05118789), a multi-center, single-arm, open-label, multi-cohort trial in participants with previously treated locally advanced or metastatic ROS1-positive NSCLC.[2] The efficacy population included 117 participants; 59 who received one prior ROS1 tyrosine kinase inhibitor and 58 who received two or more prior ROS1 tyrosine kinase inhibitors, including lorlatinib, repotrectinib, and/or taletrectinib.[2]
Society and culture
[edit]Legal status
[edit]Zidesamtinib was approved for medical use in the United States in July 2026.[5] The US Food and Drug Administration granted the application for zidesamtinib orphan drug designation.[2]
Names
[edit]Zidesamtinib is the international nonproprietary name.[6]
References
[edit]- 1 2 3 4 5 6 "Jideytro- zidesamtinib tablet, film coated". DailyMed. 22 July 2026. Retrieved 4 August 2026.
- 1 2 3 4 5 "FDA approves zidesamtinib for ROS1-positive non-small cell lung cancer". U.S. Food and Drug Administration (FDA). 22 July 2026. Retrieved 25 July 2026.
This article incorporates text from this source, which is in the public domain. - ↑ Wespiser M, Gille R, Pérol M (2026). "ROS1-positive non-small cell lung cancer: from genomics to treatment decisions". Frontiers in Oncology. 16 1739598. doi:10.3389/fonc.2026.1739598. PMC 12907153. PMID 41704605.
- ↑ "Jideytro: Uses, Dosage, Side Effects & Warnings". Drugs.com. Retrieved 23 July 2026.
- 1 2 "Novel Drug Approvals for 2026". U.S. Food and Drug Administration (FDA). 22 July 2026. Retrieved 24 July 2026.
- ↑ World Health Organization (2023). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 90". WHO Drug Information. 37 (3). hdl:10665/373341.
- ↑ "Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer". GSK. 22 July 2026. Retrieved 24 July 2026 – via PR Newswire.
External links
[edit]- Clinical trial number NCT05118789 for "A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)" at ClinicalTrials.gov
