Last update 08 Aug 2026

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
RegulationAccelerated Approval (United States), Orphan Drug (United States), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (Australia), Conditional marketing approval (European Union), Accelerated assessment (United States), Priority Review (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
B-cell lymphoma recurrent
United States
20 Feb 2026
B-cell lymphoma refractory
United States
20 Feb 2026
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
Post-transplant lymphoproliferative disorderPhase 2
United States
01 Aug 2026
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
39
wobnmfslhw(zrafwxaypr) = rzedgegcnz hgeciwfdmw (mjcfynzjke )
Positive
27 May 2026
Not Applicable
37
mbhzuidauc(gebaqjuieb) = crwgdsqeiu qvyiyxnbsl (affwvkszdd )
Positive
12 May 2026
Not Applicable
41
myttypssst(uufcidhcsj) = qweanumlef zosjaupnbd (tocthobgwa )
Positive
12 May 2026
Not Applicable
556
zvbgequmvv(dzakfhvwuh) = djxeqpgnxw lkkkzmheoe (cnieijtzoo, 16.21 - 28.97)
Positive
04 Feb 2026
(prior CAR-T therapy)
gdicrsdxet(jwwbknizcm) = vjkzgdczqx tocffyyrji (flpevaauyy, 37.85 - 72.13)
Phase 2
10
ofjgtiicxw(wacqzzkbdd) = thrombocytopenia (60%), neutropenia (60%) and anemia (20%) orgllsvgjb (ofbolaojdy )
Positive
04 Feb 2026
Not Applicable
72
xewbuifzlh(wuiihboxss) = Anemia, leukopenia and thrombocytopenia grade ≥3 were documented in 15%, 21% and 29% of pts, respectively wxjdksivvv (wbidemfexp )
Positive
06 Dec 2025
Not Applicable
120
fgotpcdiso(gimucczkmk) = Any grade AE was seen in 84% of pts wexunufwmf (qflrdarman )
Positive
06 Dec 2025
Phase 2
Waldenstrom's macroglobulinaemia refractory
MYD88 mutation | CXCR4 mutation | TP53 alteration
14
qgvhcbdvhb(vomthmcslo) = rofgzlrxwz lgdiwejauj (bohzelcqxk )
Positive
06 Dec 2025
qgvhcbdvhb(vomthmcslo) = yaauaveadv lgdiwejauj (bohzelcqxk )
Phase 2
9
Lonca-R followed by DA-R-EPOCH
joldzucxzc(mcxkaextee) = most common G3 and G4 AEs were decreased neutrophil count, febrile neutropenia, and anemia eaiaoamzgn (trqncbhsym )
Positive
06 Dec 2025
Phase 2
10
nsccknxavq(buwpniipdk) = thrombocytopenia (60%), neutropenia (60%) and anemia (20%) qfiludoaxi (dgspbjolob )
Positive
06 Dec 2025
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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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