LUTATHERA
Peaklutetium lu 177 dotatate
NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Jan 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
6
Data completeness
5/8 — Partial
Priority Review
LUTATHERA (lutetium lu 177 dotatate) is 177 dotatate binds to somatostatin receptors with highest affinity for subtype 2 somatostatin receptors (sstr2). First approved in 2018.
Drug data last refreshed 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LUTATHERA (Lutetium Lu 177 Dotatate) is a radiopharmaceutical therapeutic that targets somatostatin receptor-positive neuroendocrine tumors through receptor-mediated internalization and beta-minus emission-induced cellular damage. It is administered intravenously as a solution and represents the first approved therapeutic radiopharmaceutical in this class. The drug delivers localized radiation to tumor cells while minimizing systemic exposure.
Peak12.7 years to LOE
Product is in peak commercial lifecycle with mature market penetration; brand teams managing established market with focus on market maintenance and indication expansion.
Mechanism of Action
177 dotatate binds to somatostatin receptors with highest affinity for subtype 2 somatostatin receptors (SSTR2). Upon binding to somatostatin receptor expressing cells, including malignant somatostatin receptor-positive tumors, the compound is internalized. The beta-minus emission from lutetium-177…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
Comparing Capecitabine and Temozolomide in Combination to Lutetium Lu 177 Dotatate in Patients With Advanced Pancreatic Neuroendocrine Tumors
Started Feb 2023
31 enrolled
Metastatic Pancreatic Neuroendocrine TumorUnresectable Pancreatic Neuroendocrine Carcinoma
A Post Marketing Surveillance on Lutathera® in Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumor in Korea
Started May 2022
89 enrolled
Somatostatin Receptor-positive GEP-NET
LUTATHERA Injection General Use Result Survey
Started Dec 2021
347 enrolled
Somatostatin Receptor-positive Neuroendocrine Tumor
Telotristat With Lutathera in Neuroendocrine Tumors
Started Sep 2021
1 enrolled
Neuroendocrine Tumors
Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE (Lutathera®)
Started Sep 2021
31 enrolled
Neuroendocrine Tumor
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.