Nuvation Bio’s lung cancer drug, taletrectinib, has entered the formal review process in the United Kingdom. The Medicines and Healthcare products Regulatory Agency (MHRA) validated the Marketing Authorisation Application (MAA) submitted by partner Eisai Co., Ltd. This validation confirms the submission is complete and initiates the scientific review for treating advanced ROS1-positive non-small cell lung cancer (NSCLC).
The application utilizes the International Recognition Procedure to potentially expedite access by leveraging approvals from other trusted regulators. Data from two Phase 2 clinical studies, TRUST-I and TRUST-II, support the submission.
Taletrectinib currently holds approvals for ROS1+ NSCLC in the United States, Japan, and China. The European Medicines Agency validated a similar application in March 2026, which remains under review.