Lutetium Lu 177 dotatate

(Lutathera®)

Lutathera®

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Drug updated on 5/17/2024

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.

Summary
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  • 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.
  • Three systematic reviews/meta-analyses were examined to gather information about Lutathera's efficacy and safety profile compared to other treatments.
  • In one study focusing on adults with advanced neuroendocrine tumors previously treated with Lutathera or Y 90-PRRT, Lutathera demonstrated a median progression-free survival of over a year and an overall survival rate close to two years. The disease control rate was reported at 71%, indicating substantial effectiveness.
  • Another study focused on individuals with radioiodine refractory differentiated thyroid cancer (RR-DTC) and metastatic medullary thyroid carcinoma (MTC), where biochemical responses were observed in more than a quarter of patients, and objective responses in around ten percent. This suggests that Lutathera can be effective even against challenging cancers like RR-DTC and MTC.
  • Regarding safety, grade three or four adverse events occurred in only five percent of patients from the first study group; minimal renal toxicities along with incidents of myelodysplastic syndrome or acute myeloid leukemia were also noted, indicating that Lutathera has fewer side effects compared to some other treatments for these conditions.
  • Subgroup considerations showed similar progression-free survivals whether using lutetium Lu alone or in combination with Y90 PRRT therapy, which further emphasizes its utility as an effective therapeutic option across different scenarios, such as initial treatment or retreatment, among various types of NETs including RR-DCTC & MTC populations who have limited alternative treatments available.

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