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<p>Taletrectinib 己二酸他雷替尼膠囊 [DOVBLERON 达伯乐<sup>®</sup> (China); IBTROZI<sup>TM</sup> (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 <i>ROS1</i>-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 <i>ROS1</i>-positive NSCLC who have previously been treated with ROS1 inhibitors. Subsequently, taletrectinib was approved on 3&#xa0;January 2025 in China and on 11&#xa0;June 2025 in the USA for the treatment of adults with locally advanced or metastatic <i>ROS1</i>-positive NSCLC, and then on 19&#xa0;September 2025 in Japan for the treatment of adults with unresectable advanced and/or recurrent <i>ROS1</i>-positive NSCLC. Additional global filings for taletrectinib are underway. This article summarizes the milestones in the development of taletrectinib leading to these first approvals.</p>

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Taletrectinib: First Approval

  • 期刊论文

  • 发表日期：

    2025年11月12日

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  • Sheridan M. Hoy

摘要

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.