Taletrectinib: First Approval

<p dir="ltr"><b>Funding</b> The preparation of this review was not supported by any external funding.</p><p dir="ltr"><b>Declarations</b></p><p dir="ltr"><b>Authorship and Conflict of interest</b> During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Sheridan M. Hoy is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.</p><p dir="ltr"><b>Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability </b>Not applicable.</p><p dir="ltr">Additional information about this Adis Drug Review can be found <a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews" target="_blank"><b>here</b></a>.</p><p dir="ltr">Abstract</p><p dir="ltr">Taletrectinib 己二酸他雷替尼膠囊 [DOVBLERON 达伯乐^® (China); IBTROZI^TM (USA)] is an oral, potent, next-generation proto-oncogene tyrosine-protein kinase-1 (c-Ros oncogene-1; ROS1) inhibitor. It was developed by Nuvation Bio China Ltd., [previously AnHeart Therapeutics (Hangzhou) Co. Ltd.,], a Nuvation Bio Inc. company, under license from Daiichi Sankyo Co., Ltd., 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 January 2025 in China and on 11 June 2025 in the USA for the treatment of adults with locally advanced or metastatic <i>ROS1</i>-positive NSCLC, and then on 19 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><p dir="ltr">© The Author(s), under exclusive licence to Springer Nature Switzerland AG 2025</p>