Nuvation Bio and Eisai Apply for Taletrectinib Marketing Authorization in EU
Nuvation Bio (NUVB) and Eisai Co. (ESAIY) announced that the European Medicines Agency, or EMA, has validated the Marketing Authorisation Application, or MAA, for taletrectinib for the treatment of advanced ROS1-positive non-small cell lung cancer, or NSCLC. The filing will follow a standard review timeline. In January, 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. The application is based on data from the two pivotal Phase 2 clinical studies, TRUST-I and TRUST-II, evaluating taletrectinib in patients globally. The accepted MAA will be considered to support full approval. In June 2025, the FDA granted full approval to taletrectinib for the treatment of locally advanced or metastatic ROS1+ NSCLC across lines of therapy. Taletrectinib is also approved for patients with advanced ROS1+ NSCLC in Japan and in China.
