Nippon Kayaku announces completion of marketing authorization application of a novel ROS1 inhibitor, taletrectinib, for use in patients with advanced ROS1-positive Non-Small Cell Lung Cancer in Japan
2025/03/03Nippon Kayaku Co., Ltd. (Headquarters: Tokyo, Japan; President: Atsuhiro Wakumoto; hereinafter "Nippon Kayaku") announces that it has completed submission of a marketing authorization application for taletrectinib (development code: AB-106/DS-6051b) to the Pharmaceuticals and Medical Devices Agency (PMDA).
This application is based on the results of a global Phase II clinical study (TRUST-II) in patients with advanced ROS1-positive non-small cell lung cancer (NSCLC), which were presented at the World Conference on Lung Cancer (WCLC 2024) held in September 2024.
On November 27, 2024, taletrectinib was designated as an orphan drug by the Ministry of Health, Labour, and Welfare for the intended indication of "ROS1-positive, unresectable, advanced/recurrent non-small-cell lung cancer". The marketing authorization application for taletrectinib has been designated priority review/consultation.
Nippon Kayaku will continue its efforts to obtain marketing authorization for taletrectinib in Japan to provide new treatment options for patients with advanced ROS1-positive NSCLC.
In 2023, Nippon Kayaku entered into an exclusive license agreement with AnHeart Therapeutics Inc., a Nuvation Bio Inc. company, to market and distribute taletrectinib in Japan.
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): 203 as of September 30, 2024
(8) Past relationship with Nippon Kayaku: Capital, personal and business relationships have not previously occurred.
About Nuvation Bio
Nuvation Bio is a global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel product candidates. Nuvation Bio’s programs include taletrectinib (ROS1), safusidenib (mIDH1), NUV-1511 (DDC), and NUV-868 (BET). 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.
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. Up to 35% of patients newly diagnosed with metastatic ROS1-positive NSCLC have tumors that spread to their brain, increasing up to 55% for those whose cancer has progressed following initial treatment. 1-3 Despite recent progress for patients with ROS1-positive 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 Taletrectinib
Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1-positive NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1-positive NSCLC in two Phase II single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study.
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.
Based on pooled results of the TRUST-I and TRUST-II clinical studies, the U.S. Food and Drug Administration (FDA) has accepted for Priority Review Nuvation Bio’s New Drug Application (NDA) for taletrectinib for the treatment of patients with advanced ROS1-positive NSCLC (line agnostic, full approval) and assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2025. 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.
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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