Nippon Kayaku announces IBTROZIⓇCapsules 200mg (taletrectinib) has been approved in Japan for patients with unresectable advanced and/or recurrent ROS1-positive non-small cell lung cancer
2025/09/19Nippon Kayaku Co., Ltd. (Headquarters: Tokyo, Japan; President: Shigeyuki Kawamura; hereinafter "Nippon Kayaku") announces today that manufacturing and marketing approval has been obtained for IBTROZIⓇ Capsules 200mg(generic name: taletrectinib adipate; hereinafter, IBTROZIⓇ), which was in-licensed from Nuvation Bio Inc. (Headquarters: New York, The U.S.; Representative and CEO: David Hung, M.D.; hereinafter, Nuvation Bio), for the indication of adult patients with ROS1 fusion gene positive unresectable, advanced and/or recurrent non-small cell lung cancer (NSCLC) from the Ministry of Health, Labour and Welfare (MHLW).
The approval by the MHLW was based on results from two pivotal Phase 2 clinical studies (TRUST-I and TRUST-II). In these studies, the primary endpoints were met and favorable response were observed.
In 2023, Nippon Kayaku entered into an exclusive license agreement with AnHeart Therapeutics Inc., a Nuvation Bio Inc. company, to market and distribute IBTROZIⓇ in Japan. This approval in Japan follows regulatory approvals for IBTROZIⓇ in the same indication in the United States (June 2025) and China (December 2024).
Nippon Kayaku will continue its efforts to swiftly provide IBTROZIⓇ as a new treatment option for patients with advanced NSCLC who are positive for the ROS1 fusion gene.
For information regarding AmoyDxⓇ Pan Lung Cancer PCR Panel, which was approved as a companion diagnostic for IBTROZIⓇ, please refer to the website of RIKEN Genesis Co., Ltd.
Information of regulatory approved IBTROZIⓇ in Japan
| Trade Name | IBTROZIⓇ Capsules 200mg |
|---|---|
| Generic Name | Taletrectinib adipate |
| Date of obtaining manufacturing and marketing approval | September 19th, 2025 |
| Indication | ROS1 fusion gene positive unresectable, advanced and/or recurrent NSCLC |
| Dosage and Administration | The usual dosage for adults is 600 mg of taletrectinib administered orally once daily on an empty stomach. The dosage may be reduced according to the patient's condition. |
| Manufacturing Authorization Holder | Nippon Kayaku Co., Ltd. |
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): 278 as of June 30, 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 with the goal of developing therapies that create a profound, positive impact on patients’ lives. Nuvation Bio’s diverse pipeline includes taletrectinib (IBTROZI™), 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.
（https://nuvationbio.com）
About ROS1-positive NSCLC
Each year, more than one million people globally are diagnosed with NSCLC, the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1-positive disease 1. About 35% of patients newly diagnosed with metastatic ROS1-positive NSCLC have tumors that have spread to their brain 2. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases 2,3.
1. Journal of Clinical Oncology. 2012 Mar 10; 30 (8):863-870.
2. Journal of Thoracic Oncology. 2018 Nov; 13 (11):1717–1726
3. Lung Cancer. 2019 Apr: 130:201-207.
About IBTROZIⓇ Capsules 200mg
IBTROZI is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor therapy approved for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC cancer in the United States, China, and Japan. For U.S. prescribing information, please visit IBTROZI.com.
As for the detailed data presented at past scientific conferences, please visit Nuvation Bio’s website.
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