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DRUG:

Lutathera (lutetium Lu 177 dotatate)

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Other names: 177Lu-DOTATATE, [Lu-177]-Dota-Tyr3-Octreotate, [Lu-177]-DOTATATE, octreotate Lu-177 DOTA Tyr-3, 177Lu-[DOTA0, Tyr3] octreotate, 177Lu-DOTA0-Tyr3-octreotate, Lu-DOTATATE, 177Lu-DOTA-Octreotate, 177Lu-DOTA-tyr3-Octreotate, AAA601, AAA 601, AAA-601, [177Lu]Lu-DOTA-TATE
Company:
Novartis
Drug class:
Beta radiation emitter, SSTR2 modulator
Related drugs:
3d
FAERS based pharmacovigilance study and network pharmacology analysis of Lutathera and Pluvicto. (PubMed, Appl Radiat Isot)
This FAERS analysis characterizes agent-specific safety profiles, informing pharmacovigilance strategies. Mechanistic profiling of adverse drug reactions optimizes evidence-based treatment, enhancing medication safety and refining benefit-risk profiles in clinical practice.
Journal • Adverse events
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ROR1 (Receptor Tyrosine Kinase Like Orphan Receptor 1) • SSTR (Somatostatin Receptor)
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Lutathera (lutetium Lu 177 dotatate)
7d
Is Peptide Receptor Radionuclide Therapy Effective in the Treatment of Radioactive Iodine-Refractory Differentiated Thyroid Cancer?-A Case Report. (PubMed, Niger J Clin Pract)
This case highlights the limited therapeutic efficacy of PRRT in RAIR-DTC, despite favorable imaging characteristics. It underscores the need for better patient selection and further research to clarify the role of PRRT in this population.
Journal
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SSTR (Somatostatin Receptor)
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SSTR positive
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Lutathera (lutetium Lu 177 dotatate)
12d
GoTHAM: Targeted Therapy and Avelumab in Merkel Cell Carcinoma (clinicaltrials.gov)
P1/2, N=19, Active, not recruiting, Melanoma and Skin Cancer Trials Limited | Recruiting --> Active, not recruiting | Trial completion date: Jul 2027 --> Dec 2027 | Trial primary completion date: Jul 2027 --> Dec 2026
Enrollment closed • Trial completion date • Trial primary completion date
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Bavencio (avelumab) • Lutathera (lutetium Lu 177 dotatate)
12d
[177Lu]Lu-DOTATATE Population Pharmacokinetics and Dosimetry Modeling for Adolescent and Adult Patients with Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors. (PubMed, J Nucl Med)
Age and weight did not show a clinically significant impact on 177Lu-DOTATATE exposure or kidney and bone marrow dosimetry values, confirming that flat dosing at adult dosage is appropriate for adolescents. 177Lu-DOTATATE with 7.4 GBq of activity, administered over 4 cycles 8 wk apart, is a well-tolerated therapeutic dosing regimen for adolescent patients with gastroenteropancreatic neuroendocrine tumors or pheochromocytomas and paragangliomas.
PK/PD data • Journal
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SSTR (Somatostatin Receptor)
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SSTR positive
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Lutathera (lutetium Lu 177 dotatate)
18d
Using Novel Imaging to More Safely Treat Neuroendocrine Tumors (clinicaltrials.gov)
P1, N=10, Recruiting, University of Wisconsin, Madison | Trial completion date: Mar 2026 --> Jun 2026 | Trial primary completion date: Mar 2026 --> Jun 2026
Trial completion date • Trial primary completion date
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SSTR (Somatostatin Receptor)
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SSTR positive
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Lutathera (lutetium Lu 177 dotatate)
20d
KKS-312: Adjuvant radioligand therapy in neuroendocrine tumors (2024-518236-36-00)
P2/3, N=160, Recruiting, Philipps-Universitaet Marburg | Not yet recruiting --> Recruiting
Enrollment open
|
SSTR (Somatostatin Receptor)
|
Lutathera (lutetium Lu 177 dotatate)
22d
Trial primary completion date
|
temozolomide • Lutathera (lutetium Lu 177 dotatate)
25d
Medical Management of Well-Differentiated Pancreatic Neuroendocrine Tumors: From Conventional Therapies to Emerging Strategies. (PubMed, J Clin Med)
In patients with radiologic progression requiring systemic disease control, targeted agents such as everolimus and sunitinib represent established subsequent options, particularly when disease stabilization is the primary therapeutic goal. Peptide receptor radionuclide therapy with 177Lu-DOTATATE has demonstrated meaningful antitumor activity and is generally considered in patients with SSTR-positive tumors with progressive disease (Ki-67 ≥ 10%) or increasing tumor burdens, especially when tumor reduction is desirable. Combination cytotoxic chemotherapy, most notably the capecitabine-temozolomide (CAPTEM) regimen, remains an important consideration for patients with higher tumor burdens or more aggressive tumor biology. This review summarizes current evidence and provides a practical overview of treatment selection and sequencing for the systemic management of Grade 1-2 pancreatic neuroendocrine tumors, while also highlighting emerging therapeutic strategies, including targeted alpha therapy and SSTR2 antagonist-based approaches.
Review • Journal
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SSTR (Somatostatin Receptor) • SSTR2 (Somatostatin Receptor 2)
|
SSTR positive
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sunitinib • everolimus • temozolomide • capecitabine • Lutathera (lutetium Lu 177 dotatate)
27d
NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. (clinicaltrials.gov)
P1, N=31, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2027 --> Aug 2026 | Trial primary completion date: Jun 2027 --> Aug 2026
Trial completion date • Trial primary completion date
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TP53 (Tumor protein P53) • PTEN (Phosphatase and tensin homolog) • RB1 (RB Transcriptional Corepressor 1) • SSTR2 (Somatostatin Receptor 2) • SYP (Synaptophysin) • CHGA (Chromogranin A)
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Lutathera (lutetium Lu 177 dotatate) • AAA603
28d
Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma (clinicaltrials.gov)
P2, N=32, Active, not recruiting, NYU Langone Health | Trial primary completion date: Jan 2026 --> Apr 2025
Trial primary completion date
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SSTR2 (Somatostatin Receptor 2)
|
Lutathera (lutetium Lu 177 dotatate)
29d
Recommendations for selection, treatment, and follow-up in peptide receptor radionuclide therapy (PRRT) for neuroendocrine tumors: a Delphi consensus from the Galician Multidisciplinary Group on Neuroendocrine and Endocrine Tumors (GGNET). (PubMed, Clin Transl Oncol)
This Delphi consensus provides pragmatic, multidisciplinary, and evidence-informed guidance to harmonize routine clinical practice in the use of PRRT for well-differentiated, SSTR-positive NETs. The proposed statements and the algorithm aim to harmonize practice across centers, reduce variability in care, enhance safety, and ultimately improve patient outcomes.
Journal
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SSTR (Somatostatin Receptor)
|
SSTR positive
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Lutathera (lutetium Lu 177 dotatate)
1m
Lung Metastases from Meningioma Diagnosed on Whole Body 68Ga-DOTATOC PET/CT and Successfully Targeted With 177Lu-DOTATATE. (PubMed, Clin Nucl Med)
We report a case of meningioma brain tumor becoming refractory after initial neurosurgery and stereotactic radiotherapy. Meningioma has progressed to lung metastases displaying high expression of SSTR, and hence suitable for PRRT.
Journal
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SSTR (Somatostatin Receptor)
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Lutathera (lutetium Lu 177 dotatate)