Liu SV, Nagasaka M, Atz J, et al. Oncogenic gene fusions in cancer: from biology to therapy. Signal Transduct Target Ther. 2025;10(1):111.

Article  PubMed  PubMed Central  Google Scholar 

Nikanjam M, Okamura R, Barkauskas DA, et al. Targeting fusions for improved outcomes in oncology treatment. Cancer. 2020;126(6):1315–21.

Article  PubMed  Google Scholar 

Wu H, Li X, Li H. Gene fusions and chimeric RNAs, and their implications in cancer. Genes Dis. 2019;6(4):385–90.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Gendarme S, Bylicki O, Chouaid C, et al. ROS-1 fusions in non-small-cell lung cancer: evidence to date. Curr Oncol. 2022;29(2):641–58.

Article  PubMed  PubMed Central  Google Scholar 

Nuvation Bio Inc. IBTROZITM (taletrectinib) capsules, for oral use: US prescribing information. 2025. https://www.fda.gov/. Accessed 13 June 2025.

Nuvation Bio Inc. Nuvation Bio reports first quarter 2025 financial results and provides business update [media release]. 7 May 2025. https://nuvationbio.com/.

Daiichi Sankyo Co., Ltd., AnHeart Therapeutics Inc. Daiichi Sankyo out-licenses ROS1/NTRK inhibitor DS-6051 to AnHeart Therapeutics [media release]. 17 Dec 2018. http://www.daiichisankyo.com.

Innovent Biologics, Inc. Taletrectinib adipate capsules: Chinese prescribing information. 2024. https://www.innoventbio.com/. Accessed 30 Dec 2024.

Innovent Biologics, Inc. Innovent receives approval of DOVBLERON® (taletrectinib adipate capsule, ROS1 inhibitor) by China’s National Medical Products Administration [media release]. 20 Dec 2024. https://www.innoventbio.com/.

Innovent Biologics, Inc. Innovent announces second New Drug Application of DOVBLERON® (taletrectinib adipate capsule, ROS1 inhibitor) was approved by China’s National Medical Products Administration [media release]. 3 Jan 2025. http://www.innoventbio.com.

Nuvation Bio Inc. Nuvation Bio receives approval from China’s National Medical Products Administration for taletrectinib for patients with advanced ROS1-positive non-small cell lung cancer [media release]. 6 Jan 2025. http://www.nuvationbio.com.

Nuvation Bio Inc. U.S. Food and Drug Administration approves Nuvation Bio’s IBTROZI™ (taletrectinib), a next-generation oral treatment for advanced ROS1-positive non-small cell lung cancer [media release]. 11 Jun 2025. http://www.nuvationbio.com.

Nuvation Bio Inc. Nuvation Bio receives approval from Japan’s Ministry of Health, Labour and Welfare for IBTROZITM for patients with advanced ROS1-positive non-small cell lung cancer [media release]. 19 Sept 2025. https://nuvationbio.com/.

Nippon Kayaku Co. Ltd. Nippon Kayaku announces IBTROZIⓇ capsules 200 mg (taletrectinib) has been approved in Japan for patients with unresectable advanced and/or recurrent ROS1-positive non-small cell lung cancer [media release]. 19 Sep 2025. https://www.nipponkayaku.co.jp/

Nuvation Bio Inc. Nuvation Bio Inc., pipeline. 2025. https://nuvationbio.com/pipeline/. Accessed 25 Sept 2025.

AnHeart Therapeutics (Hangzhou) Co. Ltd. AnHeart Therapeutics announces license agreement with NewG Lab for taletrectinib rights in Korea [media release]. 15 Jul 2020. http://www.anhearttherapeutics.com.

Innovent Biologics, Inc., AnHeart Therapeutics (Hangzhou) Co. Ltd. Innovent Biologics and AnHeart Therapeutics jointly announce exclusive license agreement for taletrectinib in Greater China [media release]. 31 May 2021. http://www.innoventbio.com.

AnHeart Therapeutics (Hangzhou) Co. Ltd. AnHeart Therapeutics announces exclusive license agreement with Nippon Kayaku for taletrectinib in Japan [media release]. 30 Oct 2023. http://www.anhearttherapeutics.com.

Guardant Health Inc., AnHeart Therapeutics (Hangzhou) Co. Ltd. Guardant Health and AnHeart Therapeutics announce collaboration to develop Guardant360(R) CDx and Guardant360 TissueNext(Tm) as companion diagnostics for taletrectinib in advanced or metastatic ROS1-positive non-small cell lung cancer [media release]. 2 Feb 2023. http://www.guardanthealth.com.

AnHeart Therapeutics (Hangzhou) Co. Ltd., Foundation Medicine, Inc. AnHeart Therapeutics and Foundation Medicine announce collaboration to develop tissue-based and liquid-based companion diagnostics for taletrectinib, a ROS1 inhibitor [media release]. 14 Dec 2023. http://www.anhearttherapeutics.com.

Nuvation Bio Inc. Nuvation Bio completes acquisition of AnHeart Therapeutics [media release]. 10 Apr 2024. http://www.nuvationbio.com.

Patel HK, Heller L, Bowman K, et al. Taletrectinib, a next generation selective ROS1 inhibitor, inhibits growth of ROS1 wild-type and ROS1-G2032R xenografts [abstract no. 5612 plus poster]. Cancer Res. 2025;85(8 Suppl 1).

Katayama R, Gong B, Togashi N, et al. The new-generation selective ROS1/NTRK inhibitor DS-6051b overcomes crizotinib resistant ROS1-G2032R mutation in preclinical models. Nat Commun. 2019;10(1):1–12.

Article  Google Scholar 

Papadopoulos KP, Borazanci E, Shaw AT, et al. U.S. phase I first-in-human study of taletrectinib (DS-6051b/AB-106), a ROS1/TRK inhibitor, in patients with advanced solid tumors. Clin Cancer Res. 2020;26(18):4785–94.

Article  CAS  PubMed  Google Scholar 

Fujiwara Y, Takeda M, Yamamoto N, et al. Safety and pharmacokinetics of DS-6051b in Japanese patients with non-small cell lung cancer harboring ROS1 fusions: a phase I study. Oncotarget. 2018;9(34):23729–37.

Article  PubMed  PubMed Central  Google Scholar 

US FDA. Multi-discipline review. 2024. https://www.fda.gov/. Accessed 22 Aug 2025.

Li W, Xiong A, Yang N, et al. Efficacy and safety of taletrectinib in Chinese patients with ROS1+ non-small cell lung cancer: the phase II TRUST-I study. J Clin Oncol. 2024;42(22):2660–70.

Article  CAS  PubMed  Google Scholar 

Li W, Xiong A, Fan H, et al. Updated efficacy and safety of taletrectinib in Chinese patients with ROS1+ non-small cell lung cancer: phase 2 TRUST-I study [abstract no. P3.12.69 plus poster]. In: 2025 World Conference on Lung Cancer. 2025.

Pérol M, Li W, Pennell NA, et al. Taletrectinib in ROS1+ non-small cell lung cancer: TRUST. J Clin Oncol. 2025;43(16):1920–9.

Article  PubMed  Google Scholar 

Pérol M, Yang N, Choi CM, et al. Efficacy and safety of taletrectinib in patients (pts) with ROS1+ non-small cell lung cancer (NSCLC): interim analysis of global TRUST-II study [abstract no. 1373P plus poster]. Ann Oncol. 2023;34(Suppl 2):S788–9.

Liu G, Yang N, Choi MC, et al. Efficacy and safety of taletrectinib in patients with ROS1+ non-small cell lung cancer: the global TRUST-II study [abstract no. MA06.03 plus oral presentation]. J Thorac Oncol. 2024;19(10S):S72–3.

Liu G, Choi C-M, Sugawara S, et al. Updated efficacy and safety of taletrectinib in patients with ROS1+ non-small cell lung cancer: the global TRUST-II study [abstract no. MA02.02 plus oral presentation]. In: 2025 World Conference on Lung Cancer. 2025.

Nagasaka M, Ohe Y, Zhou C, et al. TRUST-II: a global phase II study of taletrectinib in ROS1-positive non-small-cell lung cancer and other solid tumors. Future Oncol. 2023;19(2):123–35.

Article  CAS  PubMed  Google Scholar 

Amoy Diagnostics Co., Ltd. AmoyDx® Pan Lung Cancer PCR Panel approved in Japan as the primary companion diagnostic for IBTROZI® (taletrectinib adipate) [media release]. 19 Sept 2025. https://www.amoydiagnostics.com/.