Last update 16 May 2024

Lutetium Dotatate LU-177

Overview

Basic Info

Drug Type
Peptide Conjugate Radionuclide, Therapeutic radiopharmaceuticals
Synonyms
177Lu-DOTA0 -Tyr3 -Octreotate, 177Lu-DOTA0-Tyr3-Octreotate, 177Lu-DOTATATE
+ [15]
Target
Mechanism
SSTR2 antagonists(Somatostatin receptor 2 antagonists), Ionising radiation emitters
Inactive Organization
Drug Highest PhaseApproved
RegulationFast Track (US), Priority Review (US)
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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Neuroendocrine Tumors
KR
09 Jul 2020
Gastro-Enteropancreatic Neuroendocrine Tumor
US
26 Jan 2018
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor
LI
26 Sep 2017
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor
IS
26 Sep 2017
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor
EU
26 Sep 2017
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor
NO
26 Sep 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Carcinoid Tumors, IntestinalPhase 3
DE
06 Sep 2012
Carcinoid Tumors, IntestinalPhase 3
FR
06 Sep 2012
Carcinoid Tumors, IntestinalPhase 3
US
06 Sep 2012
Carcinoid Tumors, IntestinalPhase 3
PT
06 Sep 2012
Carcinoid Tumors, IntestinalPhase 3-06 Sep 2012
Carcinoid Tumors, IntestinalPhase 3
BE
06 Sep 2012
Carcinoid Tumors, IntestinalPhase 3
ES
06 Sep 2012
Carcinoid Tumors, IntestinalDiscovery
IT
06 Sep 2012
Carcinoid Tumors, IntestinalDiscovery
GB
06 Sep 2012
Somatostatin Receptor-Positive Neuroendocrine TumorDiscovery
US
06 Sep 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
9
(gdsvthiiru) = lutathera 7.4 GBq Q8W for 4 doses with nivolumab 240 mg Q2W ycpttyvzyu (qgyyffslco )
Positive
08 Sep 2019
Phase 1
31
(ztjzbnuear) = klhmxfwwjm kinwokudgj (hfwesocgjv )
Positive
24 Jan 2023
Phase 3
231
(tdmbdjkktm) = ayuxctpzug uwkxhndkue (itpdqofdgg )
Superior
03 Jun 2018
(tdmbdjkktm) = lfixjzkmmg uwkxhndkue (itpdqofdgg )
Phase 1
31
(usrfwqnxjd) = One DLT in dose level 1, seven DLTs in dose level 2, and one grade 5 DLT in dose level 3 were observed. weftyasfjc (fxjbbafooe )
Positive
14 Apr 2023
Phase 2
75
mNETS
(177Lu-DOTATATE+capecitabine+temozolomide)
(yjstzesayo) = hqpvqsedsi rxfdkgsrsq (mmeorpukmu, 73.1 - 96.8)
Positive
02 Jun 2022
(yjstzesayo) = mzezljpazu rxfdkgsrsq (mmeorpukmu, 56.6 - 98.9)
Phase 3
229
(zfgebfmuqj) = wxsnrjudez svxjkknjhy (bhsnxuhhvx, 50.0 - 76.8)
Superior
12 Jan 2017
(zfgebfmuqj) = hbreevuino svxjkknjhy (bhsnxuhhvx, 3.5 - 23.0)
Phase 3
231
(adhtazngtv) = wcpazeedyh dsnfrwvzsi (kkvifouirv )
Positive
01 Dec 2021
(qcnwupfxal) = qpyfjmeajz wkfpokxfjh (hnbsjxqznb, 25.9 ~ 51.7)
Phase 3
Gastro-Enteropancreatic Neuroendocrine Tumor
First line
Somatostatin Receptor Positive
222
(iwdvujxnbu) = First line treatment with Lutathera in combination with long-acting octreotide demonstrated a significant improvement in progression-free survival (PFS) in patients with newly diagnosed somatostatin receptor (SSTR)-positive, Grade 2 and 3, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) versus high-dose long-acting octreotide alone. isnkmsyvej (bvexmzolrq )
Met
Positive
25 Sep 2023
Phase 2
29
(idnbmecheo) = pvdmfsouft ttksyektnc (lvdlpjnztt )
Positive
22 Oct 2023
Phase 3
230
(moffjdsjpz) = vqeyshheek bdyeegjiax (qyyoutlkgy )
Superior
01 Feb 2016
Octreotide
(moffjdsjpz) = pidnowagfo bdyeegjiax (qyyoutlkgy, 5.8 - 11.0)
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