Nuvation Bio Says Japan Approves IBTROZI For ROS1+ Advanced Non-small Cell Lung Cancer Treatment

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(RTTNews) - Oncology company Nuvation Bio Inc. (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 (ROS1+) unresectable, advanced and/or recurrent non-small cell lung cancer (NSCLC).

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. Upon the first establishment of the reimbursement price in Japan, which is anticipated in the fourth quarter of 2025, Nuvation Bio will receive a $25 million milestone payment to go towards continued progression of our pipeline and portfolio.

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.

IBTROZI is already approved for similar indication by the U.S. Food and Drug Administration (FDA) on June 11, 2025, and by China's National Medical Products Administration (NMPA) on January 6, 2025.