Marketing Authorisation Application for Taletrectinib for the Treatment of Advanced ROS1-Positive Non-Small Cell Lung Cancer Validated in the United KingdomA Marketing Authorisation Application with the European Medicines Agency is also under regulatory review for approval

• R&D

• For Print
• June 26, 2026

TOKYO, June 26, 2026 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has validated the Marketing Authorisation Application (MAA) for taletrectinib for the treatment of advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The application was submitted through the International Recognition Pathway, which takes into account approvals from trusted regulatory partners and supports expedited access to medicines in the UK. The application will now be evaluated by the MHRA to decide whether to approve or reject the application.

Taletrectinib is an oral treatment for patients living with advanced ROS1+ NSCLC.¹ In January 2026, Eisai and Nuvation Bio Inc. (NYSE: NUVB, Corporate Headquarters: New York, NY) 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.² In March 2026, the European Medicines Agency validated the MAA for taletrectinib. Additional filings are planned for Canada and other regions included in Eisai’s licensed territories.

Within the UK, there are around 50,200 new lung cancer cases every year.³ Around 80 to 85% of all lung cancers are NSCLC,⁴ of which approximately 2% of patients harbor the ROS1+ mutation.⁵

“Following regulatory progress in Europe, the submission of the MAA application to the MHRA is a meaningful milestone that contributes to advancing the global footprint of taletrectinib,” said Terushige Iike, Chief Business Officer of Eisai Co., Ltd. “We believe taletrectinib has the potential to deliver additional value to clinical practice, based on the efficacy and safety which is being assessed in clinical studies. We remain committed to working closely with the MHRA throughout the review process to help bring this additional treatment option to patients as quickly as possible.”

The application is based on data from the two pivotal Phase 2 clinical studies, TRUST-I and TRUST-II, evaluating taletrectinib in patients globally.^6,7 Results from a pooled analysis of the TRUST clinical program were initially reported in April 2025,⁸ and updated data reflecting longer patient follow-up were presented in April 2026, further building the efficacy and safety profile observed to date.⁹ Updated results from the TRUST-I study were also published at the same time in April 2026.¹⁰

* 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
  

Media Inquiries:

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Eisai Co., Ltd.

+81-(0)3-3817-5120

Notes to Editors

1. 1. 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.¹¹ It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease.⁵ About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain.¹² The brain is a common site of disease progression.^12,13

1. 2. About Taletrectinib

Taletrectinib is an oral, CNS-active, ROS1 inhibitor therapy. On June 11, 2025,  the U.S. Food and Drug Administration (FDA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Taletrectinib is also approved for patients with advanced ROS1+ NSCLC in China¹⁴ and Japan.¹⁵

1. 3. About the TRUST Clinical Program 

The TRUST clinical program evaluates 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.

1. 4. About the International Recognition Pathway (IRP) in the United Kingdom

IRP is a regulatory pathway established by the UK Medicines and Healthcare products Regulatory Agency (MHRA) that allows the agency to take into account the expertise and decision-making of trusted international reference regulators, such as the European Medicines Agency (EMA) and FDA.

Under IRP, MHRA conducts a targeted assessment based on existing regulatory evaluations, with the aim of supporting patients in the UK with expedited access to medicines.¹⁶

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