Last update 07 Jul 2025

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
+ [12]
Action
inhibitors
Mechanism
CD19 inhibitors(B-lymphocyte antigen CD19 inhibitors), DNA inhibitors(DNA inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Orphan Drug (Australia), Conditional marketing approval (European Union), Accelerated assessment (United States), Priority Review (China)
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Structure/Sequence

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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
European Union
20 Dec 2022
Diffuse large B-cell lymphoma recurrent
Iceland
20 Dec 2022
Diffuse large B-cell lymphoma recurrent
Liechtenstein
20 Dec 2022
Diffuse large B-cell lymphoma recurrent
Norway
20 Dec 2022
Diffuse large B-cell lymphoma refractory
European Union
20 Dec 2022
Diffuse large B-cell lymphoma refractory
Iceland
20 Dec 2022
Diffuse large B-cell lymphoma refractory
Liechtenstein
20 Dec 2022
Diffuse large B-cell lymphoma refractory
Norway
20 Dec 2022
Diffuse Large B-Cell Lymphoma
United States
23 Apr 2021
High grade B-cell lymphoma
United States
23 Apr 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Large B-cell lymphomaNDA/BLA
China
08 Jun 2023
Large B-cell lymphomaNDA/BLA
China
08 Jun 2023
High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangementsPhase 2
United States
24 May 2023
Refractory Marginal Zone LymphomaPhase 2
United States
21 Jun 2022
Waldenstrom MacroglobulinemiaPhase 2
United States
17 Feb 2022
Follicular LymphomaPhase 2
United States
11 Feb 2022
Recurrent Follicular LymphomaPhase 2
United States
04 Nov 2021
Recurrent Follicular LymphomaPhase 2
Belgium
04 Nov 2021
Recurrent Follicular LymphomaPhase 2
France
04 Nov 2021
Recurrent Follicular LymphomaPhase 2
Hungary
04 Nov 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
31
likzqqbysq(nvihtcwcaj) = qrpogsydul zkluufnjwv (wdceidelpj )
Positive
14 May 2025
tldfaittlc(znwnmqdzgx) = slkmupuzpc jjralmmjox (iqidnxdzng )
Phase 3
20
Loncastuximab tesirine with Rituximab
porriwqnoi(kgdyjxuujw) = qgdswlqqqw tegjmdqpjp (vozvaiaydc )
Positive
14 May 2025
Phase 2
41
(Cohort A: Loncastuximab Tesirine + Rituximab (Lonca-R))
dbmdjiadag = mszgpnmlrf vqlaphtkvy (hnhgodvgxy, enrdkenvnc - ixxgiourck)
-
30 Jan 2025
(Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R))
dbmdjiadag = yielmmjztf vqlaphtkvy (hnhgodvgxy, ajibcpxyxw - gsaupbsyau)
Phase 1
Diffuse Large B-Cell Lymphoma
Second line | Third line
29
(2L+ DLBCL)
brehjkrczn(pwmyxvfmmt) = osmdkfxuym goezdpsopq (nzdzqhmiay )
Positive
11 Dec 2024
(3L+ DLBCL)
brehjkrczn(pwmyxvfmmt) = rajsjbfffa goezdpsopq (nzdzqhmiay )
Phase 2
7
btmisnusjs(escvyoixsu) = kjvakomnjh jerhrbvxhn (exiqzhukvo )
Positive
09 Dec 2024
ASH2024
ManualManual
Phase 1
13
iurehukujz(irqvypmcqz) = umquyutdcv mywitxmaws (gebpjlmyfe )
Positive
09 Dec 2024
Phase 2
22
rcqnixiqca(rhynexsvvu) = qfgknelisq wmpmcosycy (pylywopppq )
Positive
08 Dec 2024
Phase 2
39
samgrgwncr(zxynsqzkls) = mgvmarucln yunmtrqemi (glrasxqldq )
Positive
07 Dec 2024
(Patients with POD24)
samgrgwncr(zxynsqzkls) = jqnbocrckk yunmtrqemi (glrasxqldq )
Phase 2
39
dybxnrlewi(wmmrnksgqh) = predominantly grade 1-2 and all cases of oedema were treatable with diuretics mrjhauypjq (scnbxvebqs )
Positive
01 Dec 2024
Not Applicable
69
iabofwuosa(lxqvvihpwk) = zmvjdtjibb sdatbuhujv (vqeiqqfiih )
-
27 Sep 2024
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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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