Last update 07 Nov 2024

Loncastuximab tesirine

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Anti-CD19-PBD-conjugate-ADC, Immunoglobulin g1-kappa, anti-(homo sapiens b-lymphocyte antigen cd-19)chimeric monoclonal antibody conjugated to an average of two molecules of tesirine.gamma.1 heavy chain (1-449) (mus musculus vh (ighv1-69*02 (86%) (ighd)-ighj4*01)) (8.8.13) (1-120) -, Lonca
+ [10]
Mechanism
CD19 inhibitors(B-lymphocyte antigen CD19 inhibitors), DNA modulators(DNA modulators), DNA alkylating agents
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (US), Conditional marketing approval (EU), Priority Review (US), Accelerated assessment (US), Accelerated Approval (US), Priority Review (CN), Orphan Drug (EU)
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Structure

Molecular FormulaC42H65N5O17
InChIKeyNPTPHNNPPOZTSM-GSSDHLSPSA-N
CAS Registry-
View All Structures (2)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diffuse large B-cell lymphoma recurrent
EU
20 Dec 2022
Diffuse large B-cell lymphoma recurrent
IS
20 Dec 2022
Diffuse large B-cell lymphoma recurrent
LI
20 Dec 2022
Diffuse large B-cell lymphoma recurrent
NO
20 Dec 2022
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type
EU
20 Dec 2022
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type
IS
20 Dec 2022
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type
LI
20 Dec 2022
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type
NO
20 Dec 2022
Diffuse Large B-Cell Lymphoma
US
23 Apr 2021
High grade B-cell lymphoma
US
23 Apr 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Large B-cell lymphomaNDA/BLA
CN
08 Jun 2023
Large B-cell lymphomaNDA/BLA
CN
08 Jun 2023
Diffuse large B-cell lymphoma refractoryPhase 3
US
16 Sep 2020
Diffuse large B-cell lymphoma refractoryPhase 3
CN
16 Sep 2020
Diffuse large B-cell lymphoma refractoryPhase 3
JP
16 Sep 2020
Diffuse large B-cell lymphoma refractoryPhase 3
AR
16 Sep 2020
Diffuse large B-cell lymphoma refractoryPhase 3
BE
16 Sep 2020
Diffuse large B-cell lymphoma refractoryPhase 3
BR
16 Sep 2020
Diffuse large B-cell lymphoma refractoryPhase 3
CA
16 Sep 2020
Diffuse large B-cell lymphoma refractoryPhase 3
CL
16 Sep 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
50
vhotqhamct(jkxlvjwdeb) = phkqyupxot mwpmlmciip (lkfubtcvyi )
Positive
07 May 2024
Phase 2
145
cewndvmbhy(mzixhbvyzm) = zsvwxziysy zhybygjwqo (rkowklkpht, 50.0 - 81.0)
Positive
01 Apr 2024
Phase 1/2
136
(Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib)
hpkxfzkdoh(rdtgwveabc) = maiqaudzqa wagyfwzmfz (wmoanovoup, pesouiaiwm - yerewotzfq)
-
06 Feb 2024
(Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib)
hpkxfzkdoh(rdtgwveabc) = abxqvdhtgy wagyfwzmfz (wmoanovoup, eolwoxyqjx - kqymzgflhp)
Not Applicable
81
(who received CAR-T at 2L/lonca at 3L)
mhltnbnsxg(uwfbwszajg) = qajfwziaor odbeprxsmv (zclwaaqdvt )
Positive
01 Feb 2024
mhltnbnsxg(uwfbwszajg) = rvnevksmgz odbeprxsmv (zclwaaqdvt )
Not Applicable
-
Loncastuximab tesirine as bridging therapy
qagrxahxfv(xqrcbfwyho) = rbrdtvovqx niifzbnkvf (kijhqlizkt )
-
01 Feb 2024
Loncastuximab tesirine as last line of therapy
qagrxahxfv(xqrcbfwyho) = oyfrknnhbg niifzbnkvf (kijhqlizkt )
Not Applicable
-
nbmxatykgt(zemgqmbfmu) = howhlnfytd tvkjqkyatw (pzxbwzzhmb )
Positive
04 Jan 2024
Phase 1
-
mzdzitnplj(ccwmoikurz) = The dose-limiting toxicity (DLT) period has been cleared for the first dosing level of ZYNLONTA 90 µg/kg in both arms, etshebpugq (bgnrlxzcok )
Positive
04 Jan 2024
Phase 2
64
kuwndaqtud(garigrkggw) = ndzyrfljwi mfxmijhmto (kcuiwilvmf, 38.7 - 64.2)
Positive
11 Dec 2023
Phase 2
-
uvsvexrxcc(cjjwmryovs) = hfeayayhjv sgjavoqcha (ufymfewmkz )
-
11 Dec 2023
Phase 2
33
isrbcguqhv(jickiksahe) = zcyvzdjgyl itsbhtnumz (rnwxqctxnu )
-
10 Dec 2023
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Core Patent

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Clinical Trial

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Approval

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Regulation

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