Lu 177 dotatate is the first FDA-approved peptide receptor radionuclide therapy

Approved lutetium Lu 177 dotatate (Lutathera) for the treatment of somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.

Lutetium Lu 177 dotatate is a radiolabeled somatostatin analog.

It is a form of targeted treatment comprising a targeting molecule that carries a radioactive component.

The approval included tumors of the foregut, midgut, and hindgut.

NETTER-1 trial, which included 229 patients with progressive, well-differentiated, locally advanced, inoperable, or metastatic somatostatin receptor–positive midgut carcinoid tumors randomly assigned to lutetium Lu 177 dotatate every 8 weeks for up to 4 administrations plus long-acting octreotide, or the standard of care: high-dose long-acting octreotide.

The median progression-free survival was not yet reached in patients assigned lutetium Lu 177 dotatate compared with 8.5 months in the high-dose long-acting octreotide group.

Significantly delays time to deterioration in the quality of life in patients with progressive midgut neuroendocrine tumors.

This translated into a 79% reduction in the risk of disease progression or death.

Interim analysis of overall survival that showed a 48% reduction in the risk of death with lutetium Lu 177 dotatate compared with standard of care.

The objective response rate with lutetium Lu 177 dotatate was 13% compared with 4% for high-dose long-acting octreotide.

The most common adverse events in the intervention arm of NETTER-1 were lymphopenia, increased gamma-glutamyltransferase, vomiting, nausea, and elevated AST

In addition, with a median follow-up of 2 years, 2.7% of patients in the lutetium Lu 177 dotatate arm developed myelodysplastic syndromes compared with no patients in the comparison arm.

The efficacy of lutetium Lu 177 dotatate was also evaluated in a subset of 360 patients enrolled in a study of GEP-NET tumors at the Erasmus Medical Center in the Netherlands: patients had an overall response rate of 16%, including three complete responses.