The UK’s MHRA Validates Marketing Authorisation Application for Taletrectinib for the Treatment of Advanced ROS1-Positive Non-Small Cell Lung Cancer – Eisai

Eisai Co., Ltd. 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. In January 2026, Eisai and Nuvation Bio Inc. 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. 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. Around 80 to 85% of all lung cancers are NSCLC, of which approximately 2% of patients harbor the ROS1+ mutation.

“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 II clinical studies, TRUST-I and TRUST-II, evaluating taletrectinib in patients globally. Results from a pooled analysis of the TRUST clinical program were initially reported in April 2025, and updated data reflecting longer patient follow-up were presented in April 2026, further building the efficacy and safety profile observed to date. Updated results from the TRUST-I study were also published at the same time in April 2026.