Drug updated on 3/28/2024
| Dosage Form | Injection (intravenous; 370 MBq/mL (10 mCi/mL)) |
| Drug Class | Radiolabeled somatostatin analogs |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Lutathera is 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. | 2022 | Advanced Accelerator Applications USA, Inc., NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Gastroenteropancreatic neuroendocrine neoplasms: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. | 2020 | Annals of Oncology |