On March 27, 2026 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai"), a human-centered global leading research-based pharmaceutical company working in the neurology and oncology therapeutic areas, and Nuvation Bio Inc. (NYSE: NUVB, Corporate Headquarters: New York, NY, CEO: David Hung, M.D., "Nuvation Bio"), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for taletrectinib for the treatment of advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The filing will follow a standard review timeline.
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Taletrectinib (marketed as IBTROZI in the U.S. and Japan) is a highly selective, next-generation oral treatment for patients living with advanced ROS1+ NSCLC. In January 2026, Eisai and Nuvation Bio announced they had entered into an exclusive licensing and collaboration agreement in Europe and additional countries* outside the U.S., China and Japan to extend the global reach of taletrectinib. Following this filing to the EMA, additional filings are planned for the U.K., Canada and other regions included in Eisai’s licensed territories.
Across Europe, nearly 400,000 people are diagnosed with lung cancer each year, with NSCLC accounting for 80% of cases. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease.
"The validation of the MAA is a significant moment for patients in Europe with ROS1+ NSCLC," said Terushige Iike, Chief Business Officer of Eisai Co., Ltd. "With its efficacy and safety profile, we believe taletrectinib has the potential to become a standard of care therapy for the thousands of patients living with this aggressive disease in Europe. We look forward to working closely with the EMA during the review process with the goal of making this treatment available to appropriate patients who urgently need targeted options."
The application is based on data from the two pivotal Phase 2 clinical studies, TRUST-I and TRUST-II, evaluating taletrectinib in patients globally. Results from a pooled analysis of the TRUST clinical program were published in the Journal of Clinical Oncology in April 2025, and Nuvation Bio anticipates near-term disclosure of updated data reflecting even longer patient follow-up, further building on the depth and durability of responses observed to date. Additionally, given the comprehensive nature of the taletrectinib clinical dataset and based on favorable feedback received at a pre-submission meeting with the CHMP Rapporteur and Co-Rapporteur, the accepted MAA will be considered to support full approval.
"Having seen the meaningful impact taletrectinib has already made for patients with ROS1+ NSCLC in the U.S., China and Japan, we are thrilled to partner with Eisai and have an accepted MAA for review in Europe," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "This accepted filing represents an important milestone in our global development strategy and brings us one step closer to delivering this highly selective, next-generation oral therapy to more patients who need it in Europe and around the world."
In June 2025, the U.S. Food and Drug Administration (FDA) granted full approval to taletrectinib for the treatment of locally advanced or metastatic ROS1+ NSCLC across lines of therapy, following a Priority Review and double Breakthrough Therapy designations. Taletrectinib is also approved for patients with advanced ROS1+ NSCLC in Japan, where it is marketed by Nippon Kayaku, and in China, where it is marketed by Innovent Biologics under the brand name DOVBLERON.
* Eisai’s licensed territories: Europe, the Middle East, North Africa, Russia, Turkey, Canada, Australia, New Zealand, Singapore, the Philippines, Indonesia, Thailand, Malaysia, Vietnam and India.
About ROS1+ NSCLC
Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases.
About Taletrectinib
Taletrectinib is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naive and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more about taletrectinib in the U.S. at IBTROZI.com.
About the TRUST Clinical Program
The TRUST clinical program comprises three registrational studies evaluating the safety and efficacy of taletrectinib. TRUST-I (NCT04395677) and TRUST-II (NCT04919811) are Phase 2 single-arm studies evaluating taletrectinib for the treatment of adults with advanced ROS1+ NSCLC in China (N=173) and globally (N=189), respectively. The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating taletrectinib for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China. The primary endpoint is disease-free survival as determined by investigator, and the primary completion date is estimated to be in 2030. Nuvation Bio is also sponsoring TRUST-III (NCT06564324), a confirmatory randomized Phase 3 study evaluating taletrectinib versus crizotinib in 138 patients in China with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs.
(Press release, Eisai, MAR 27, 2026, View Source [SID1234663939])