NEW YORK– Nuvation Bio Inc. (NYSE: NUVB) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved IBTROZI (taletrectinib) for the treatment of adult patients with ROS1-positive unresectable, advanced, or recurrent non-small cell lung cancer (NSCLC). Nippon Kayaku will market the drug in Japan under an exclusive license agreement signed in 2023.
The approval was based on pivotal Phase 2 TRUST studies evaluating taletrectinib in patients worldwide, including Japan. A pooled analysis of the TRUST program, published in April 2025 in the Journal of Clinical Oncology, demonstrated high response rates and durable benefit for patients.
In parallel, MHLW cleared the AmoyDx PLC Panel as a companion diagnostic to identify patients with locally advanced or metastatic ROS1-positive NSCLC who may benefit from IBTROZI treatment.
“Building on the regulatory approvals for IBTROZI in the U.S. and China, this additional approval by the MHLW further underscores the best-in-class potential and promise that IBTROZI holds for patients living with advanced ROS1-positive non-small cell lung cancer around the globe,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “We remain steadfastly committed to bringing forward innovative cancer treatments that can help patients stay ahead of their disease.”
The U.S. Food and Drug Administration granted full approval to IBTROZI on June 11, 2025, for the treatment of locally advanced or metastatic ROS1-positive NSCLC across lines of therapy, following Priority Review and two Breakthrough Therapy designations. Shortly afterward, the National Comprehensive Cancer Network added taletrectinib (IBTROZI) as a Preferred Agent in its NSCLC Clinical Practice Guidelines, including specific recommendations for patients with brain metastases and resistance mutations.
In January 2025, China’s National Medical Products Administration also approved taletrectinib for adults with locally advanced or metastatic ROS1-positive NSCLC, regardless of prior ROS1 tyrosine kinase inhibitor treatment. In China, the therapy is marketed by Innovent Biologics as DOVBLERON.
Nuvation Bio expects Japan to establish reimbursement pricing in the fourth quarter of 2025. At that time, the company will receive a $25 million milestone payment to support continued development of its oncology pipeline.
