Chemistry:Zidesamtinib

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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

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

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

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

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

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

Zidesamtinib is the international nonproprietary name.[6]

Zidesamtinib is sold under the brand name Jideytro.[5][7]

References

  1. ↑ 1.0 1.1 1.2 1.3 1.4 Cite error: Invalid <ref> tag; no text was provided for refs named Jideytro FDA label
  2. ↑ 2.0 2.1 2.2 2.3 2.4 "FDA approves zidesamtinib for ROS1-positive non-small cell lung cancer". U.S. Food and Drug Administration (FDA). 22 July 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zidesamtinib-ros1-positive-non-small-cell-lung-cancer.  Public Domain This article incorporates text from this source, which is in the public domain.
  3. ↑ "ROS1-positive non-small cell lung cancer: from genomics to treatment decisions". Frontiers in Oncology 16. 2026. doi:10.3389/fonc.2026.1739598. PMID 41704605. 
  4. ↑ "Jideytro: Uses, Dosage, Side Effects & Warnings". Drugs.com. https://www.drugs.com/jideytro.html. 
  5. ↑ 5.0 5.1 "Novel Drug Approvals for 2026". U.S. Food and Drug Administration (FDA). 22 July 2026. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026. 
  6. ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 90". WHO Drug Information 37 (3). 2023. 
  7. ↑ "Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer". GSK. 22 July 2026. https://www.prnewswire.com/news-releases/jideytro-zidesamtinib-approved-in-the-us-for-previously-treated-ros1-positive-non-small-cell-lung-cancer-302832452.html. 
  • 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



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