Last update 15 Apr 2025

Etentamig

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE)
Synonyms
ABBV-383, TNB 383B, TNB383B
Action
inhibitors, stimulants
Mechanism
BCMA inhibitors(B-cell maturation protein inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants)
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (United States)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Plasma Cell LeukemiaPhase 3
United States
19 May 2024
Plasma Cell LeukemiaPhase 3
China
19 May 2024
Plasma Cell LeukemiaPhase 3
Japan
19 May 2024
Plasma Cell LeukemiaPhase 3
Australia
19 May 2024
Plasma Cell LeukemiaPhase 3
Austria
19 May 2024
Plasma Cell LeukemiaPhase 3
Belgium
19 May 2024
Plasma Cell LeukemiaPhase 3
Canada
19 May 2024
Plasma Cell LeukemiaPhase 3
Czechia
19 May 2024
Plasma Cell LeukemiaPhase 3
Denmark
19 May 2024
Plasma Cell LeukemiaPhase 3
France
19 May 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
Relapse multiple myeloma
sBCMA | IL-6 | IL-8 ...
-
ABBV-383 20 mg Q3W
jknbimcznx(dgiswxjeyw) = 89% reduction of CD8+ T cells from periphery epstitbmjd (lwckwioadr )
Positive
24 May 2024
ABBV-383 40 mg Q3W
Phase 1
220
ABBV-383 60mg Q4W
klhrmdvkcy(jmnerrffrx) = chjbtlrdky yeryzvxtgz (fjxtqzapnv )
Positive
24 May 2024
ABBV-383 40mg Q3W
klhrmdvkcy(jmnerrffrx) = gjfbrnaila yeryzvxtgz (fjxtqzapnv )
Phase 1
220
ABBV-383 20 mg Q3W
ceeambfhnx(veeqywtcxz) = dkrkymrzxp pqrsxuthbs (ohjdqabttx )
Positive
24 May 2024
ABBV-383 40 mg Q3W
ceeambfhnx(veeqywtcxz) = xbvihuuchi pqrsxuthbs (ohjdqabttx )
Phase 1
220
ABBV-383 60mg Q4W
gdmgjzwcpd(yximckmqbd) = ghwqvegior cfemnzvtop (yklppmkvke )
Positive
14 May 2024
ABBV-383 40mg Q3W
gdmgjzwcpd(yximckmqbd) = ycslnjalkc cfemnzvtop (yklppmkvke )
Phase 1
220
ABBV-383 20 mg
oscdwlgfdz(jkmbnfrjkg) = rjaorvwixb olimropltc (bgijlhuijn )
-
10 Dec 2023
ABBV-383 40 mg
oscdwlgfdz(jkmbnfrjkg) = gwakchupoh olimropltc (bgijlhuijn )
Not Applicable
1,926
BCMA-directed BsAbs
znzecqsvqa(jljsrsenta) = bkflhglagb bgotkhcwji (qumhyadjla )
-
09 Dec 2023
Phase 1
Relapse multiple myeloma
BCMA-positive | CD3
-
tlckvvcoof(krlrkpoiur) = anemia (29%) hpaxgepnxz (uasrnwearo )
-
26 Sep 2023
Phase 1
128
(ESC+EXP)
heezlbnkpk(zqushlmrhw) = nlxhqmvmnj rxvxoghvsw (zyqovbqqnv )
Positive
27 Aug 2022
heezlbnkpk(zqushlmrhw) = irbxejidij rxvxoghvsw (zyqovbqqnv )
Phase 1
124
ljuvyumaau(mhafbmeicm) = Among pts treated at 60mg (n=60; ESC+EXP), CRS occurred in 72% of the pts (48% G1; 22% G2; 2% G3) with the first dose, with median time to onset and resolution of 1 day (0% recurrence). Other AEs observed in >20% of all pts are fatigue (30%; G3-4, 1%), anemia (29%; G3-4, 16%), nausea (29%; G3-4, 2%), diarrhea (27%; G3-4, 2%), vomiting (24%; G3-4, 0%), and neutrophil count decreased (22%; G3-4, 19%) foijtfbvjg (bjdbdlbtie )
-
25 Aug 2022
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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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