For which indications are 177lu Dotatate peptide receptor radionuclide therapy approved by the FDA?

177Lu Dotatate (Lutathera) is a radiolabeled somatostatin analog peptide approved by the FDA for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. Specifically, 177Lu Dotatate is indicated for:

Treatment of somatostatin receptor-positive GEP-NETs including foregut, midgut, and hindgut neuroendocrine tumors in adults

Locally advanced or metastatic GEP-NETs

Key points:

177Lu Dotatate binds to somatostatin receptors (particularly sst2 receptors) on tumor cells. The attached radioactive Lutetium-177 delivers targeted radiation to tumor sites to kill cancerous cells

Approval was based on the NETTER-1 phase 3 trial demonstrating significant improvement in progression-free survival with 177Lu Dotatate compared to high-dose octreotide LAR

Indications Supported by Clinical Evidence

The NETTER-1 trial that supported FDA approval evaluated 177Lu Dotatate in patients with the following inclusion criteria:

Well-differentiated, somatostatin receptor-positive neuroendocrine tumors

Locally advanced or metastatic midgut tumors with progression by RECIST within the prior 12 months

The trial enrolled and treated patients with the following specific neuroendocrine tumor types:

Ileal and small bowel NETs

Pancreatic NETs

Lung NETs

Colonic NETs

177Lu Dotatate resulted in:

65% reduction in risk of disease progression or death vs high-dose octreotide LAR

Ability to control tumors in ~2/3 of progressive small bowel NET patients

Based on these positive phase 3 results, FDA approval covers somatostatin receptor-positive GEP-NETs of the:

✔️ Foregut (e.g. lung, pancreas)

✔️ Midgut (e.g. small bowel)

✔️ Hindgut (e.g. colorectal)

This includes locally advanced, unresectable, or metastatic tumors.

Vitality Hormone Center Specializes in Neuroendocrine Tumors

If you have been diagnosed with a neuroendocrine tumor such as a GEP-NET, the hormone therapy experts at Vitality Hormone Center can help.

We specialize in using natural hormone balancing therapy and lifestyle changes to help patients improve their quality of life when facing illnesses like neuroendocrine tumors. Examples of our holistic programs include: