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

Clinical Breakthrough

TL;DR

Lutathera, the first EMA-approved radiopharmaceutical for treating certain neuroendocrine tumors, showed improved progression-free survival but faced concerns for expanded use in high-grade tumors.

Analysis

Lutathera's approval as the first EMA-authorized radiopharmaceutical for certain neuroendocrine tumors signifies a significant advancement in treatment options, notably enhancing progression-free survival rates. However, concerns over its expanded use in high-grade tumors highlight the importance of ongoing monitoring and evaluation of its efficacy and safety in different patient populations.