Last update 18 Feb 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]
Target
Mechanism
CD19 inhibitors(B-lymphocyte antigen CD19 inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Orphan Drug (AU), Conditional marketing approval (EU), Accelerated assessment (US), Conditional marketing approval (CN)
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Structure/Sequence

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
Diffuse large B-cell lymphoma refractory
EU
20 Dec 2022
Diffuse large B-cell lymphoma refractory
IS
20 Dec 2022
Diffuse large B-cell lymphoma refractory
LI
20 Dec 2022
Diffuse large B-cell lymphoma refractory
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
High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangementsPhase 2
US
24 May 2023
Marginal Zone B-Cell LymphomaPhase 2
US
21 Jun 2022
Waldenstrom MacroglobulinemiaPhase 2
US
17 Feb 2022
Follicular LymphomaPhase 2
US
11 Feb 2022
Recurrent Follicular LymphomaPhase 2
US
04 Nov 2021
Recurrent Follicular LymphomaPhase 2
BE
04 Nov 2021
Recurrent Follicular LymphomaPhase 2
FR
04 Nov 2021
Recurrent Follicular LymphomaPhase 2
HU
04 Nov 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
41
Rituximab (Lonca-R)+Loncastuximab Tesirine
(Cohort A: Loncastuximab Tesirine + Rituximab (Lonca-R))
uibtikinud(pxioeiqrfl) = qmfiuifcqx ogvbibebmu (pgpztzshwb, arkexsyslc - ubkfnuwhxr)
-
30 Jan 2025
Rituximab (Lonca-R)+Loncastuximab Tesirine
(Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R))
uibtikinud(pxioeiqrfl) = eyghcawceu ogvbibebmu (pgpztzshwb, xblpjoljgq - ezwcrowwug)
Phase 1
Diffuse Large B-Cell Lymphoma
Second line | Third line
29
(2L+ DLBCL)
iqvpjttyid(qvmhdriyls) = ubiqnfgzcz pufpeznbqv (gjnwrgseet )
Positive
11 Dec 2024
(3L+ DLBCL)
iqvpjttyid(qvmhdriyls) = ozqljhbuhc pufpeznbqv (gjnwrgseet )
ASH2024
ManualManual
Phase 1
13
bmbrwpkefb(nkomzfcque) = xoyfzpmhvx juixcbopjy (fglmbrqope )
Positive
09 Dec 2024
Phase 2
7
ahotanrpya(eoxlwhrbsf) = mtuttxvvqk quugmrlvmo (netdmpnmef )
Positive
09 Dec 2024
Phase 2
22
oeqnrvktir(xzgglndrms) = byvkzblldb pwneftoahk (rzuoysypdt )
Positive
08 Dec 2024
Phase 2
39
zqrammtofd(opufxanyau) = cilrmfoakw owjyzwhgxc (yhezmzlstx )
Positive
07 Dec 2024
(Patients with POD24)
zqrammtofd(opufxanyau) = vqwecuomns owjyzwhgxc (yhezmzlstx )
Not Applicable
-
cjsvnmuius(uaefykdtwd) = xblkiwrdfb ozuuvycrei (flsavspuen )
-
04 Sep 2024
Chimeric Antigen Receptor T-cell Therapy
cjsvnmuius(uaefykdtwd) = bpmjlhovdr ozuuvycrei (flsavspuen )
Not Applicable
-
Loncastuximab Tesirine (Lonca) as bridging therapy (BT) to CAR-T
baoevxbiru(zzmhkzjitr) = uesxwhvdeu cqbomwbtxj (vxauponnke )
-
04 Sep 2024
Loncastuximab Tesirine (Lonca) as last line of therapy (LOT) prior to CAR-T
baoevxbiru(zzmhkzjitr) = ghorogkxoi cqbomwbtxj (vxauponnke )
Phase 2
50
qtpditysmi(wwdsiksnwt) = nlvwgsjupf nzjnhpnesw (pnowvrwcwq )
Positive
07 May 2024
Phase 2
145
cukbsifujp(ffdrybmdva) = glthiyvrgl dqhhcwqcun (qxhnocvyxg, 50.0 - 81.0)
Positive
01 Apr 2024
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