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

177Lu Dotatate is a radiolabeled somatostatin analog peptide approved by the FDA in January 2018 for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. 177Lu Dotatate binds to somatostatin receptors, which are overexpressed on neuroendocrine tumor cells. After binding to the receptors, 177Lu emits therapeutic beta radiation directly to the tumor cells and surrounding area, providing targeted radiation therapy.

The approval of 177Lu Dotatate was based on the results of the NETTER-1 phase III clinical trial. This trial compared treatment with 177Lu Dotatate plus octreotide LAR to treatment with high-dose octreotide LAR alone in patients with inoperable, progressive, somatostatin receptor-positive midgut NETs. The trial enrolled 229 patients who were randomized 1:1 to either arm. The primary endpoint was progression-free survival (PFS).

The results of the NETTER-1 trial demonstrated that treatment with 177Lu Dotatate resulted in markedly improved PFS compared to octreotide LAR alone. The estimated PFS at month 20 was 65.2% in the 177Lu Dotatate arm vs 10.8% in the control arm. This corresponded to a 79% reduction in risk of disease progression or death with 177Lu Dotatate (hazard ratio 0.21, p<0.0001).

Objective response rates were also significantly higher with 177Lu Dotatate (18%) vs octreotide LAR alone (3%), with a median duration of response of 17 months at data cut-off. The safety profile was consistent with radiation exposure, with low rates of grade 3 hematologic toxicity. Most common toxicities (>20%) were lymphopenia, nausea and vomiting, and fatigue.

Based on these results, the FDA approved 177Lu Dotatate (NETSPOT) in January 2018 for the treatment of adult patients with somatostatin receptor-positive GEP-NETs, such as foregut, midgut, hindgut neuroendocrine tumors. It is the first FDA-approved peptide receptor radionuclide therapy (PRRT) for GEP-NETs in the US.

The National Comprehensive Cancer Network (NCCN) guidelines recommend 177Lu Dotatate as a systemic therapy option for GEP-NETs in various settings:

• For unresectable or metastatic disease, 177Lu Dotatate is a first-line therapy option.


• For locoregional advanced or metastatic disease, 177Lu Dotatate can be used after failure of first-line somatostatin analogues.


• For localized disease, 177Lu Dotatate may be considered for select patients to facilitate surgical resection.

The guidelines note that tumor somatostatin receptor status should be confirmed with a Ga-68 Dotatate PET/CT scan prior to PRRT. Pre-medication with amino acids is also recommended to decrease renal toxicity.

At Harmony Hormone Clinic, we provide 177Lu Dotatate therapy for qualified patients with metastatic gastroentero-pancreatic neuroendocrine tumors (GEP-NETs). Our multidisciplinary team includes experienced nuclear medicine physicians and endocrinologists who are experts in delivering peptide receptor radionuclide therapy. We offer a comfortable, patient-focused environment with supportive care before, during and after treatment. Contact us today to find out if you are a candidate for this innovative therapy.