Nippon Kayaku announces IBTROZITM approved in the U.S. for patients with advanced ROS1-positive Non-Small Cell Lung Cancer
2025/06/12Nippon Kayaku Co., Ltd. (Headquarters: Tokyo, Japan; President: Atsuhiro Wakumoto; hereinafter "Nippon Kayaku") announces that Nuvation Bio Inc. (Headquaters: New York, The U.S.; Representative and CEO: David Hung, M.D.; hereinafter, Nuvation Bio) obtained full approval of IBTROZITM (taletrectinib) in the U.S. for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC).
The approval by the U.S. Food and Drug Administration (FDA) was based on results from the two Phase II pivotal clinical studies (TRUST-I and TRUST-II). The U.S. FDA has accepted for priority review Nuvation Bio’s New Drug Application (NDA) for IBTROZITM for the treatment of patients with advanced ROS1-positive NSCLC (line agnostic, full approval).
Please visit Nuvation Bio’s website to refer to the detailed information.
(https://investors.nuvationbio.com/news/news-details/2025/U-S--Food-and-Drug-Administration-Approves-Nuvation-Bios-IBTROZI-taletrectinib-a-Next-Generation-Oral-Treatment-for-Advanced-ROS1-Positive-Non-Small-Cell-Lung-Cancer/default.aspx)
In 2023, Nippon Kayaku entered into an exclusive license agreement with AnHeart Therapeutics Inc., a Nuvation Bio Inc., to market and distribute taletrectinib in Japan. Nippon Kayaku submitted a Marketing Authorization Application for taletrectinib in Japan and will continue its efforts to obtain marketing authorization for taletrectinib in Japan to provide a new treatment options for patients with advanced ROS1-positive NSCLC.
Reference information
Outline of Nuvation Bio Inc.
(1) Name: Nuvation Bio Inc.
(2) Headquarters: 1500 Broadway, Suite 1401, New York, NY 10036
(3) Representative and CEO: David Hung, M.D.
(4) Established: 2018
(5) Fiscal Year End: December 31
(6) Main Business: Biotechnology
(7) Number of employees (including affiliates): 273 as of March 31, 2025
(8) Past relationship with Nippon Kayaku: Capital, personal and business relationships have not previously occurred.
About Nuvation Bio
Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment by developing therapies that create a profound, positive impact on patients’ lives. Their diverse pipeline includes IBTROZIⓇ (taletrectinib), a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor; NUV-1511, an innovative drug-drug conjugate (DDC) designed for targeted cancer treatment; and NUV-868, a BD2-selective BET inhibitor.
Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world’s leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai.
About ROS1 gene fusion
ROS1 is an enzyme protein called tyrosine kinase that is involved in cell growth. ROS1 gene fusion is formed by the fusion of the ROS1 gene and a part of a partner gene. ROS1 gene fusion has been confirmed in various cancers, including NSCLC, and the proliferation of cancer cells can be suppressed by suppressing the function of ROS1.
About ROS1-positive NSCLC
Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1-positive disease. About 35% of patients newly diagnosed with metastatic ROS1-positive NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing CNS metastases.1-3 Despite recent progress for patients with ROS1+ NSCLC, there remains a need for more effective and tolerable treatment options.
1. Journal of Clinical Oncology. 2012 Mar 10; 30 (8):863-70.
2. Journal of Thoracic Oncology. 2018 Jul 5; 13 (11):1717–1726
3. Lung Cancer. 2019 Apr: 130:201-207.
About IBTROZITM (Taletrectinib)
Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor therapy approved for the treatment of adult patients with advanced ROS1-positive NSCLC in the U.S. and China. In Japan, Nippon Kayaku announced submission of a marketing authorization application for taletrectinib in March 2025.
The results from the TRUST-I study, which was conducted in China were presented at the American Society of Clinical Oncology (ASCO) 2024. The results from the TRUST-II study, which enrolled almost a quarter of patients in Japan, were presented at WCLC 2024. The pooled results from the TRUST-I and TRUST-II studies were presented at the European Society for Medical Oncology (ESMO) 2024 and published in Journal of Clinical Oncology (Journal of Clinical Oncology. 2025 Apr 3:JCO2500275. doi: 10.1200/JCO-25-00275).
The U.S. FDA previously granted taletrectinib Breakthrough Therapy Designation for the treatment of patients with locally advanced or metastatic ROS1-positive NSCLC who either have or have not previously been treated with ROS1 TKIs, and Orphan Drug Designation for the treatment of patients with ROS1-positive NSCLC and other NSCLC indications. In January 2025, China’s National Medical Products Administration (NMPA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.
About the TRUST Clinical Program
The TRUST clinical program evaluating taletrectinib for the treatment of adult patients with advanced ROS1-positive NSCLC included two Phase II single-arm pivotal studies: TRUST-I (NCT04395677) in China, which enrolled 173 patients, and TRUST-II (NCT04919811), a global study, which enrolled 164 patients. The primary endpoint of these registrational studies is confirmed objective response rate (cORR) as assessed by an independent review committee (IRC). Key secondary endpoints include intracranial cORR, duration of response, progression-free survival, and safety.
Please visit Nuvation Bio’s website to refer to the detailed data presented at past scientific conferences. (https://www.nuvationbio.com/publications/)
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