Drug updated on 5/10/2024
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.
Summary
- Lutetium Lu 177 dotatate (Lutathera) is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.
- Two systematic reviews/meta-analyses were reviewed to gather information about this drug's effectiveness and safety profile.
- A meta-analysis showed that re-treatment with lutetium Lu 177 dotatate provided a median progression-free survival of approximately 12 months in patients with NETs previously treated with PRRT; overall survival was around 27 months while disease control rate was at 71%.
- The same study found that grade three or four adverse events occurred in only five percent of patients receiving lutetium Lu 177 dotatate re-treatment, indicating a favorable safety profile similar to initial PRRT treatments.
- Another review compared the clinical effectiveness and cost-effectiveness literature on everolimus, lutetium-177 DOTATATE (Lutathera), and sunitinib for treating advanced unresectable or metastatic progressive NETs; it concluded that only sunitinib might be considered good value for money based on list prices but did not provide specific data regarding Luthatera's cost-effectiveness ratio per quality-adjusted life-year gained.
- This second review also noted more frequent reporting of adverse events following treatment with targeted interventions like Luthatera than after best supportive care alone; however, no direct comparison between these drugs' side effect profiles was made.
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 |