November 20, 2025
Human medicines European public assessment report (EPAR): Lutathera, lutetium (177Lu) oxodotreotide, Date of authorisation: 26/09/2017, Revision: 18, Status: Authorised
IntelME Verdict
Regulatory Approval
TL;DR
EMA authorised Lutathera for GEP-NETs in 2017, with Advanced Accelerator Applications as the holder. An application extension for high-grade GEP-NETs was withdrawn in 2025 due to concerns.
Analysis
The EMA's approval of Lutathera for GEP-NETs in 2017 marked a significant milestone in radiopharmaceutical development, offering a new treatment option with improved progression-free survival. The withdrawal of the application for high-grade GEP-NETs in 2025 highlights the regulatory challenges and importance of addressing unresolved concerns in expanding indications.
Share: