Nuvation Bio Secures Japan Approval for IBTROZI™ in ROS1-Positive Advanced NSCLC, Strengthening Global Expansion of Its Oncology Portfolio
Nuvation Bio Inc. (NYSE: NUVB), a global oncology company dedicated to advancing innovative treatments for some of the most challenging cancers, has achieved a major regulatory milestone in Japan. The company announced today 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, or recurrent non-small cell lung cancer (NSCLC). This approval marks a significant step forward for Nuvation Bio as it expands the global reach of its oncology pipeline and reinforces its commitment to delivering targeted therapies for patients with high unmet needs.
Under an exclusive license agreement signed with Nippon Kayaku in 2023, the Japanese pharmaceutical company will be responsible for commercializing IBTROZI in Japan. This partnership allows Nuvation Bio to leverage Nippon Kayaku’s established commercial infrastructure and oncology expertise to efficiently bring the therapy to patients across the country.
The MHLW’s decision was primarily based on clinical data from the pivotal Phase 2 TRUST program, a global trial evaluating the safety and efficacy of taletrectinib in patients with ROS1+ NSCLC. The program included a cohort of Japanese patients, allowing regulators to assess the therapy’s performance in the local population. A pooled analysis of the TRUST program was published in the Journal of Clinical Oncology in April 2025, further validating the clinical benefit of taletrectinib. The data demonstrated robust anti-tumor activity and a favorable safety profile, confirming the potential of IBTROZI as a preferred therapeutic option for patients with ROS1+ NSCLC.
In addition to the approval of IBTROZI itself, the MHLW also approved the AmoyDx® PLC Panel as a companion diagnostic. This diagnostic tool is designed to identify patients with locally advanced or metastatic ROS1+ NSCLC who may benefit from treatment with taletrectinib. By combining targeted therapy with precision diagnostics, clinicians can now more accurately select patients most likely to respond to treatment, ensuring optimal outcomes and minimizing unnecessary exposure to therapy.
Dr. David Hung, Founder, President, and Chief Executive Officer of Nuvation Bio, highlighted the significance of this approval, stating, “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. We remain steadfastly committed to bringing forward innovative cancer treatments that can help patients stay ahead of their disease.”
This approval in Japan is part of a broader global expansion strategy for IBTROZI. Earlier in 2025, the U.S. Food and Drug Administration (FDA) granted full approval for IBTROZI in the treatment of locally advanced or metastatic ROS1+ NSCLC, across lines of therapy. The FDA’s decision followed a Priority Review and recognition of the therapy with double Breakthrough Therapy designations, highlighting the agency’s acknowledgment of taletrectinib’s potential to address significant unmet medical needs in this patient population.
Following the U.S. approval, the National Comprehensive Cancer Network® (NCCN) incorporated taletrectinib (IBTROZI) into the NCCN Clinical Practice Guidelines® in Oncology for Non-Small Cell Lung Cancers (NSCLC). The therapy was designated as a Preferred Agent for both first-line and subsequent therapy in patients with ROS1+ NSCLC. Importantly, the NCCN Guidelines now include specific recommendations for the treatment of patients with brain metastases and those who have developed resistance mutations, further emphasizing the versatility and clinical utility of taletrectinib.
The regulatory approvals in Japan, the U.S., and China underscore the growing recognition of taletrectinib as a transformative therapy in the treatment landscape of ROS1+ NSCLC. In China, the National Medical Products Administration (NMPA) approved taletrectinib on January 6, 2025, for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC, irrespective of prior treatment with ROS1 tyrosine kinase inhibitors (TKIs). In China, the therapy is marketed under the brand name DOVBLERON® by Innovent Biologics, demonstrating the company’s strategic approach to global commercialization through partnerships and licensing agreements.
From a financial perspective, the approval in Japan is expected to trigger a milestone payment for Nuvation Bio. Upon the first establishment of the reimbursement price, which is anticipated in the fourth quarter of 2025, the company is set to receive USD $25 million. These funds will be directed toward further development of Nuvation Bio’s pipeline, supporting the advancement of additional oncology programs and innovative treatments aimed at patients with high unmet medical needs.
The approval of IBTROZI in Japan also reflects the broader trend of increasing global focus on precision oncology. ROS1+ NSCLC is a rare molecular subset of lung cancer, accounting for approximately 1–2% of all NSCLC cases. These patients often have limited treatment options, particularly after developing resistance to standard ROS1 inhibitors. Taletrectinib, a next-generation ROS1-targeted TKI, addresses these unmet needs by demonstrating activity in patients with previously treated disease, including those with brain metastases, a population historically challenging to manage.
Nuvation Bio’s approach to oncology has consistently focused on the development of targeted therapies that provide meaningful clinical benefits while maintaining a favorable safety profile. IBTROZI’s approval in multiple regions exemplifies the company’s commitment to advancing therapies that combine efficacy, tolerability, and global accessibility. The collaboration with Nippon Kayaku ensures that patients in Japan will have timely access to this therapy, while leveraging local expertise in oncology commercialization.
Looking ahead, Nuvation Bio plans to continue its efforts in expanding access to IBTROZI globally and exploring additional indications where ROS1-targeted therapy may provide benefit. The company’s broader oncology portfolio includes programs focused on hard-to-treat cancers, with an emphasis on precision medicine approaches, biomarker-driven clinical trials, and collaborations with leading research institutions.
Dr. Hung emphasized the company’s vision, noting, “Our mission is to transform the standard of care for patients with challenging cancers. The approval of IBTROZI in Japan, alongside our recent approvals in the U.S. and China, highlights the global impact of our strategy and the dedication of our team to bring forward innovative therapies that can improve patient outcomes worldwide.”
In summary, Nuvation Bio’s regulatory approval of IBTROZI in Japan represents a key milestone in the global development of a next-generation therapy for ROS1+ NSCLC. The therapy’s clinical data, combined with the approval of the AmoyDx® PLC Panel as a companion diagnostic, provides a comprehensive framework for precision medicine in this patient population. With a strategic partnership with Nippon Kayaku, Nuvation Bio is well-positioned to deliver meaningful clinical benefits to patients in Japan while continuing its global expansion of IBTROZI.
As the oncology community increasingly embraces targeted therapies and precision diagnostics, Nuvation Bio’s achievements underscore the potential for next-generation ROS1 inhibitors to reshape the treatment landscape for patients with advanced NSCLC. The company remains focused on advancing its oncology pipeline, leveraging strategic collaborations, and prioritizing the needs of patients worldwide, solidifying its position as a leader in the development of innovative cancer treatments.
