Nuvation Bio's IBTROZI Gets Approval in Japan for Advanced Lung Cancer Treatment

Nuvation Bio's IBTROZI has been approved by Japan's Ministry of Health, Labour and Welfare for the treatment of ROS1-positive advanced non-small cell lung cancer. The approval is based on data from the Phase 2 TRUST clinical program and comes after similar approvals from the US FDA and China's NMPA. Nippon Kayaku will commercialize IBTROZI in Japan, and Nuvation Bio will receive a $25 million milestone payment upon reimbursement price establishment in Q4 2025.

Nuvation Bio, Inc. (NYSE: NUVB) has received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for its oral, next-generation ROS1 inhibitor, IBTROZI (taletrectinib), to treat adult patients with ROS1-positive (ROS1+) unresectable, advanced, and/or recurrent non-small cell lung cancer (NSCLC). This approval follows similar regulatory recognitions from the U.S. Food and Drug Administration (FDA) and China's National Medical Products Administration (NMPA).

The approval by the MHLW was based on data from the pivotal Phase 2 TRUST clinical program, which demonstrated high response rates and durability of responses. Nippon Kayaku will commercialize IBTROZI in Japan under an exclusive license agreement. In parallel, the MHLW also approved the AmoyDx® PLC Panel as a companion diagnostic to identify patients eligible for IBTROZI treatment.

David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, commented, "This additional approval by the MHLW underscores the promise that IBTROZI holds for patients living with advanced ROS1-positive non-small cell lung cancer around the globe. We remain committed to bringing innovative cancer treatments forward."

In the U.S., IBTROZI received full approval from the FDA in June 2025 for locally advanced or metastatic ROS1+ NSCLC across lines of therapy. It was also added to the National Comprehensive Cancer Network (NCCN) Guidelines® as a Preferred Agent for both first-line and subsequent therapy for ROS1+ NSCLC.

Nuvation Bio will receive a $25 million milestone payment upon the establishment of the reimbursement price in Japan, anticipated in the fourth quarter of 2025. This payment will support continued progress in the company's pipeline and portfolio.