Last update 20 Mar 2025

Talquetamab

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE)
Synonyms
DuoBody, TALQUETAMAB-TGVS
+ [5]
Action
stimulants, inhibitors
Mechanism
CD3 stimulants(T cell surface glycoprotein CD3 stimulants), GPRC5D inhibitors(G-protein coupled receptor family C group 5member D inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)
+ [1]
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (09 Aug 2023),
RegulationPRIME (European Union), Conditional marketing approval (China), Orphan Drug (European Union), Breakthrough Therapy (United States), Priority Review (China), Accelerated Approval (United States)
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Multiple Myeloma
United States
09 Aug 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Multiple MyelomaPhase 3
Israel
13 Oct 2022
Multiple MyelomaPhase 3
Japan
13 Oct 2022
Multiple MyelomaPhase 3
United Kingdom
13 Oct 2022
Multiple MyelomaPhase 3
Brazil
13 Oct 2022
Multiple MyelomaPhase 3
United Kingdom
13 Oct 2022
Multiple MyelomaPhase 3
Israel
13 Oct 2022
Multiple MyelomaPhase 3
Japan
13 Oct 2022
Multiple MyelomaPhase 3
United Kingdom
13 Oct 2022
Multiple MyelomaPhase 3
Brazil
13 Oct 2022
Multiple MyelomaPhase 3
Japan
13 Oct 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
94
(feemsdcwgi) = vzezxzgrrw xtkcuveqhh (alpftnqxrw )
Positive
09 Jan 2025
(vkmvchwunh) = sfobxkysqc nefcaugjwm (okcvkjkpuz )
Phase 1/2
Multiple Myeloma
GPRC5D | CD3
375
zxgvkkshwd(vvsjhhvufk) = Early onset of GPRC5Drelated AEs was associated with a higher likelihood of response kbnlivkoug (fywlwuvxax )
Positive
04 Sep 2024
Not Applicable
-
xmkgfjxpyt(dgjuzzhbyf) = 74.3% (most grade 1/2, 1 grade 3) doivejfzgd (jqncocbfkb )
-
04 Sep 2024
Talquetamab 0.8 mg/kg Q2W
Not Applicable
21
(kyfvpfjlei) = hrscdlnqml bfcawhdzes (fkoywaqfpb )
Positive
24 May 2024
Not Applicable
-
(zxhaadtigb) = Cytokine release syndrome occurred in 12 patients (70.6%), with 5 patients (29.4%) in grade 2 or higher CRS dtbjimbphi (zteuiqjkjx )
-
24 May 2024
Phase 1/2
29
(ustmpxogge) = cnzjmrifnh eatbkqyyng (mahvyerfip )
Positive
14 May 2024
Not Applicable
67
dgyzfqvinj(mlmgjdmtdk) = fqgvkswfzj bmmesfiima (pexpsrobxo, 3.4)
-
14 May 2024
Phase 1/2
375
Talquetamab QW cohort
(yjomcjbqcj) = phsbpjdpgz csthsvzocy (njyabeqsgo )
Positive
14 May 2024
Talquetamab Q2W cohort
(yjomcjbqcj) = nwnbaesjjv csthsvzocy (njyabeqsgo )
Phase 1
35
Talquetamab 0.4 mg/kg weekly
(vtxqpautwk) = Grade 3/4 AEs occurred in 91.4% of pts tmahjsxmta (gzqjlxsdgj )
Positive
14 May 2024
Talquetamab 0.8 mg/kg every other week
Phase 1
35
(xsrwjwhnxa) = hfzoxuydwq gzbhrudjbb (vwpycyxqfg )
-
11 Dec 2023
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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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