Japanese pharmaceutical company Eisai Co Ltd (TYO:4523) and US-based oncology company Nuvation Bio Inc (NYSE:NUVB) announced on Thursday 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, the partners said.

Taletrectinib (marketed as IBTROZI in the US and Japan) is a highly selective, next-generation oral treatment for patients living with advanced ROS1+ NSCLC.

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 programme were published in the Journal of Clinical Oncology in April 2025, and Nuvation Bio anticipates near-term disclosure of updated data reflecting longer patient follow-up, further building on the depth and durability of responses observed to date.

Given the comprehensive nature of the taletrectinib clinical dataset and based on favourable feedback received at a pre-submission meeting with the CHMP Rapporteur and Co-Rapporteur, the accepted MAA will be considered to support full approval.

Eisai and Nuvation Bio announced in January 2026 they had entered into an exclusive licensing and collaboration agreement in Europe and additional countries outside the United States, China and Japan to extend the global reach of taletrectinib. Following this filing to the EMA, filings are planned for the UK, Canada and other regions included in Eisai's licensed territories.