The longer range of the beta particles emitted by 90Y, which deliver the therapeutic effect, may make it more suitable for large tumors with 177Lu reserved for smaller volumes[8][9] The US Food and Drug Administration (FDA) considers 177Lu dotatate to be a first-in-class medication.

[3][6][7] In the EU, lutetium (177Lu) oxodotreotide 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.

[9][12][13] The European Commission approved lutetium (177Lu) oxodotreotide (brand name Lutathera) "for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults" in September 2017.

[6] The US Food and Drug Administration (FDA) approved 177Lu dotatate based primarily on evidence from one clinical trial, NETTER-1 of 229 participants with somatostatin-receptor positive midgut GEP-NETs.

[15] The benefit of 177Lu dotatate was evaluated by measuring the length of time that tumors did not grow after treatment and compared it to the control group (progression free survival).

[16] Approval for children aged 12 years and older was based on pharmacokinetic, dosimetry, and safety data from NETTER-P (NCT04711135), an ongoing, international, multi-center, open-label, single-arm study of lutetium Lu 177 dotatate in adolescents with locally advanced/inoperable or metastatic SSTR-positive gastroenteropancreatic neuroendocrine tumors or pheochromocytoma/paraganglioma.

[16] The major outcome measures were absorbed radiation doses in target organs and incidence of adverse reactions after the first treatment cycle.