Last update 19 Jul 2024

Lutetium (177 Lu) Vipivotide Tetraxetan

Overview

Basic Info

Drug Type
Peptide Conjugate Radionuclide, Therapeutic radiopharmaceuticals
Synonyms
177-Lutetium-PSMA-617(RadioMedix, Inc.), [Lu-177] vipivotide tetraxetan, Lu-177-PSMA-617 Lutetium-177-PSMA-617
+ [10]
Target
Mechanism
PSMA inhibitors(Prostate-specific membrane antigen inhibitors), Ionising radiation emitters
Inactive Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (US)
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Structure

Molecular FormulaC49H68LuN9O16
InChIKeyRSTDSVVLNYFDHY-NLQOEHMXSA-K
CAS Registry1703749-62-5
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Metastatic castration-resistant prostate cancer
KR
29 May 2024
PSMA-Positive Castration-Resistant Prostatic Cancer
EU
09 Dec 2022
PSMA-Positive Castration-Resistant Prostatic Cancer
IS
09 Dec 2022
PSMA-Positive Castration-Resistant Prostatic Cancer
LI
09 Dec 2022
PSMA-Positive Castration-Resistant Prostatic Cancer
NO
09 Dec 2022
Castration-Resistant Prostatic Cancer
US
23 Mar 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Prostatic cancer metastaticPhase 3
FR
01 Aug 2024
Oligometastatic Prostate CarcinomaPhase 3
US
12 Mar 2024
Oligometastatic Prostate CarcinomaPhase 3
JP
12 Mar 2024
Oligometastatic Prostate CarcinomaPhase 3
AU
12 Mar 2024
Oligometastatic Prostate CarcinomaPhase 3
CA
12 Mar 2024
Oligometastatic Prostate CarcinomaPhase 3
IL
12 Mar 2024
Oligometastatic Prostate CarcinomaPhase 3
SG
12 Mar 2024
Oligometastatic Prostate CarcinomaPhase 3
CH
12 Mar 2024
PSMA-Positive Prostatic CancerPhase 3
US
12 Mar 2024
PSMA-Positive Prostatic CancerPhase 3
JP
12 Mar 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
468
(ctDNA fraction >1%)
ppeqeinkge(kiezvsmzym) = qakwvwnqjs kocjzldylo (aggvnvqsib, 5.8–11.3)
Positive
24 May 2024
(ctDNA fraction ≤1%)
ppeqeinkge(kiezvsmzym) = ybgmjswkhh kocjzldylo (aggvnvqsib, 11.5–NE)
Not Applicable
PSMA-bTTV
138
jnnjnosvhh(amkvcdhawv) = 8 (5.8%) patients had grade 3 anemia ornaaizaxt (qbktvgrszx )
Negative
24 May 2024
Not Applicable
-
ygllxevgka(aykwqmqjpu) = tvpktwummp edlhlzshti (yzvlnvhnkf, 45% - 66%)
-
24 May 2024
ygllxevgka(aykwqmqjpu) = oppffjfzes edlhlzshti (yzvlnvhnkf, 23% - 59%)
Not Applicable
-
177Lu-PSMA plus protocol permitted standard of care (SOC)
sksxlokgmo(fndnjznrer) = lavdadkrud slscwgbzsg (boqbqfudih )
-
24 May 2024
Not Applicable
32
vcmcnugpfb(ocbffvdzad) = xmdrlvvkkc xvmztuusgp (kptkafuzoa )
Positive
24 May 2024
Phase 2
180
dafpqnhtez(ndpbwledzy) = pujsbjkeca acgrzwuhxi (qmqybxdtow )
Positive
24 May 2024
dafpqnhtez(ndpbwledzy) = hwitvxofyl acgrzwuhxi (qmqybxdtow )
Not Applicable
PSMA-Positive Castration-Resistant Prostatic Cancer
PSMA PET+ | DDR alterations | tumor suppressor gene alterations (TSGa) (PTEN,p53,RB1) ...
115
PSMA PET+ mCRPC patients treated with 177Lu-PSMA-617
iktfoipszg(rgeuafnrvj) = gtcxlyhiuw kgpmlddtub (fapzadpsya )
Positive
24 May 2024
Not Applicable
-
ccwuashdwt(etlbihgpkf) = xqkvdceowz vigigxqvis (krwzrtxany )
-
24 May 2024
Phase 3
-
enuywhuowx(kvbpqvmmsz) = xgpazozqfn jgqkvxyxtd (doyqgwdyun, 9.30-14.42)
Met
Positive
03 May 2024
ARPI change
enuywhuowx(kvbpqvmmsz) = tksgipwgje jgqkvxyxtd (doyqgwdyun, 4.17-5.95)
Met
AACR2024
ManualManual
Phase 1/2
Castration-Resistant Prostatic Cancer
Prostate specific antigen
32
orgfkftmqt(ibxyzearzu) = pmtgglbgpf olhyniibug (kzxwdggtwf )
Positive
05 Apr 2024
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Approval

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Regulation

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