Nuvation Bio (NYSE: NUVB), a New York-based global oncology company involved in cancer treatment, announced on Monday that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) has validated the Marketing Authorisation Application (MAA) submitted by its Japan-based partner Eisai Co, Ltd. (TYO: 4523), for taletrectinib for the treatment of advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC).

The company says that the application was submitted through the International Recognition Procedure, 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.

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 US, 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.

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 originally published in the Journal of Clinical Oncology in April 2025, and updated data reflecting longer patient follow-up were presented at the American Association for Cancer Research (AACR) Annual Meeting in April 2026, further building the efficacy and safety profile observed to date. Updated results from the TRUST-I study were also simultaneously published in April 2026 in the Journal of Clinical Oncology.