Lutetium (177Lu) oxodotreotide

Lutetium (177Lu) oxodotreotide (Lutathera, Novartis Europharm Limited) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: Somatostatin receptor (1).
Approved indications of Lutetium (177Lu) oxodotreotide
Biomarker requirementRegimenSettingConditions
Neuroendocrine tumours1
Somatostatin receptor-positive
Monotherapy
Any line
advanced
Gastroenteropancreatic NET only; Progressive; well-differentiated (G1 and G2)
Full text of section 4.1 (therapeutic indications)

Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well-differentiated (G1 and G2), somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults.

Label history

21 changes to the Lutathera label since 2019, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes