Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 370 MBq/mL (10 mCi/mL)) |
Drug Class | Radiolabeled 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
- 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 Title | Year | Source |
---|---|---|
Lutathera (lutetium Lu 177 dotatate) Prescribing Information. | 2023 | Advanced Accelerator Applications USA, Inc., NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Clinical best practices for radiation safety during lutetium-177 therapy. | 2023 | Health Physics |
A clinical guide to peptide receptor radionuclide therapy with 177Lu-dotatate in neuroendocrine tumor patients. | 2022 | Cancers |
ACR-ACNM-ASTRO-SNMMI practice parameter for Lutetium-177 (Lu-177) Dotatate therapy. | 2022 | American Journal of Clinical Oncology |
Gastroenteropancreatic neuroendocrine neoplasms: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. | 2020 | Annals of Oncology |
NANETS/SNMMI procedure standard for somatostatin receptor–based peptide receptor radionuclide therapy with 177Lu-DOTATATE. | 2019 | The Journal of Nuclear Medicine |