Nuvation Bio Inc. (NYSE: NUVB) shares began Friday in the positive. The global oncology company focused on tackling some of the toughest challenges in cancer treatment today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved IBTROZITM (taletrectinib) for the treatment of adult patients with ROS1-positive (ROS1+) unresectable, advanced and/or recurrent non-small cell lung cancer. As part of an exclusive license agreement entered in 2023, Nippon Kayaku will commercialize IBTROZI in Japan.
The approval by Japan’s MHLW was based on data from the pivotal Phase 2 TRUST clinical program evaluating taletrectinib in patients globally, including Japan. Results from a pooled analysis of the TRUST clinical program were published in the Journal of Clinical Oncology in April 2025.
In parallel, the MHLW also approved the AmoyDx® PLC Panel as a companion diagnostic to identify patients with locally advanced or metastatic ROS1+ NSCLC who may benefit from treatment with IBTROZI.
“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 Nuvation CEO David Hung,
“We remain steadfastly committed to bringing forward innovative cancer treatments that can help patients stay ahead of their disease.”
NUVB shares gained five cents, or 1.4%, to $3.22.
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