Lutetium Lu 177 dotatate

(Lutathera®)

Lutetium Lu 177 dotatate

Drug updated on 9/4/2024

Dosage FormInjection (intravenous; 370 MBq/mL (10 mCi/mL))
Drug ClassRadiolabeled somatostatin analogs
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.

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Summary
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  • Lutathera (lutetium Lu 177 dotatate) is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.
  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • Median Progression-Free Survival (PFS) in patients re-treated with ^177Lu-PRRT was 12.52 months (95% CI 9.82-15.22), with a median Overall Survival (OS) of 26.78 months (95% CI 18.73-34.83), and a Disease Control Rate (DCR) of 71% (95% CI 66-75).
  • In patients with differentiated thyroid cancer (RR-DTC), the biochemical response was 25.3%, and the objective response was 10.5%. For metastatic medullary thyroid carcinoma (MTC), the biochemical response was 37.2%, and the objective response was 10.6%.
  • The Disease Response Rate (DRR) in neuroendocrine tumors (NETs) was 27.58% (95% CI 21.03-35.27%) by RECIST criteria and 20.59% (95% CI 10.89-35.51%) by SWOG criteria, with Disease Control Rates (DCR) of 79.14% (95% CI 75.83-82.1%) and 78.28% (95% CI 74.39-81.72%) respectively.
  • Grade 3/4 adverse events occurred in 5% of patients (95% CI 2-8), with few grade 3/4 renal toxicities (0% [95% CI 0-1]), and no cases of Myelodysplastic Syndrome or Acute Myeloid Leukemia (0% [95% CI 0-2]).
  • Minimal adverse effects reported, including fatigue, nausea, vomiting, and hormonal disorders.
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Lutathera (lutetium Lu 177 dotatate) Prescribing Information.2023Advanced Accelerator Applications USA, Inc., NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines