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Drugs

Taletrectinib: First Approval

  • 12-11-2025
  • NSCLC
  • AdisInsight Report
Published in:
Author
Sheridan M. Hoy
Published in
Drugs | Issue 2/2026

Abstract

Taletrectinib 己二酸他雷替尼膠囊 [DOVBLERON 达伯乐® (China); IBTROZITM (USA)] is an oral, potent, next-generation proto-oncogene tyrosine-protein kinase-1 (c-Ros oncogene-1; ROS1) inhibitor developed by Nuvation Bio China Ltd., a Nuvation Bio Inc. company, for the treatment of advanced ROS1-positive non-small cell lung cancer (NSCLC). Taletrectinib received its first approval on 20 December 2024 in China for the treatment of adults with locally advanced or metastatic ROS1-positive NSCLC who have previously been treated with ROS1 inhibitors. Subsequently, taletrectinib was approved on 3 January 2025 in China and on 11 June 2025 in the USA for the treatment of adults with locally advanced or metastatic ROS1-positive NSCLC, and then on 19 September 2025 in Japan for the treatment of adults with unresectable advanced and/or recurrent ROS1-positive NSCLC. Additional global filings for taletrectinib are underway. This article summarizes the milestones in the development of taletrectinib leading to these first approvals.
Title
Taletrectinib: First Approval
Author
Sheridan M. Hoy
Publication date
12-11-2025
Publisher
Springer International Publishing
Published in
Drugs / Issue 2/2026
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-025-02256-z
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Keynote webinar | Spotlight on dry eye disease

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  • Webinar | 28-05-2026 | 13:00 (CEST)

DED is highly prevalent yet challenging to diagnose and treat. Join leading experts to explore the latest developments and gain practical guidance on effective management in busy clinical settings. Brought to you by Springer Medicine and Eye.

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