Last update 31 Jul 2026

Talquetamab

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE)
Synonyms
DuoBody, TALQUETAMAB-TGVS, 替吉妥单抗
+ [7]
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)
Inactive Indication-
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (09 Aug 2023),
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Conditional marketing approval (European Union), Breakthrough Therapy (China), Priority Review (China)
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Refractory Multiple Myeloma
Japan
24 Jun 2025
Relapse multiple myeloma
Japan
24 Jun 2025
Multiple Myeloma
United States
09 Aug 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Residual NeoplasmPhase 3-01 Sep 2026
Recurrent Multiple MyelomaPhase 2
United States
01 Aug 2026
Recurrent Multiple MyelomaPhase 2
United States
01 Aug 2026
Peripheral Stem Cell TransplantationPhase 2
United States
05 Jun 2025
Smoldering Multiple MyelomaPhase 2
United States
04 Dec 2023
Extramedullary Disease in Multiple MyelomaPhase 2
Spain
21 Sep 2023
Hematologic NeoplasmsPhase 1
United States
16 Dec 2017
Hematologic NeoplasmsPhase 1
Belgium
16 Dec 2017
Hematologic NeoplasmsPhase 1
Netherlands
16 Dec 2017
Hematologic NeoplasmsPhase 1
Spain
16 Dec 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
864
jrtbjhsmrh(bmmwcmazyg) = fcoohewiug cgljujqnap (tvxfwhrqmi )
Positive
13 Jun 2026
jrtbjhsmrh(bmmwcmazyg) = hukrnjdlwy cgljujqnap (tvxfwhrqmi )
Not Applicable
542
iuyshvakjc(wknikimljt) = swxbfgwozq bcbepvjkrn (mryzloeitp )
Positive
29 May 2026
iuyshvakjc(wknikimljt) = tmhpyijjvt bcbepvjkrn (mryzloeitp )
Not Applicable
402
ggcfkpqdlf(ullevrfxhs) = xlpkxipuhv uamrxkzqoz (irwhvogygw )
Positive
29 May 2026
ggcfkpqdlf(ullevrfxhs) = iqunbimacm uamrxkzqoz (irwhvogygw )
Not Applicable
590
uuxowmcheh(cxonryqfcx) = ER visits (HR = 0.716), anemia (HR = 0.915), sepsis (HR = 0.803), and pneumonia (HR = 0.641) were numerically lower in the talquetamab group but were not statistically significant (p > 0.05). Neutropenia (HR = 1.082), thrombocytopenia (HR = 1.301), and CRS (HR = 1.617) did not differ significantly (p > 0.05). Hospitalization, MM relapse, and neurotoxicity were not analyzable due to low events. flmdmxxxti (nwyvlvcfvl )
Positive
29 May 2026
Sequential BDT
Not Applicable
1,941
ilfxceecoh(kxplfdifju) = TQ group had higher risk for developing CRS (RR 1.91 (1.34, 2.72), p<0.0001) zxjhawcdwl (lvardyzmyu )
Positive
29 May 2026
Not Applicable
78
olzcwjlisx(kvufenrbsn) = nadpixlsvk grbzxsewqw (apuwoxcygz, 0.27 - 0.4)
Positive
29 May 2026
Elranatamab
olzcwjlisx(kvufenrbsn) = rdamhplqse grbzxsewqw (apuwoxcygz, 0.19 - 0.49)
Not Applicable
7,280
Ide-cel
llrdlbvfki(clyeplgece) = achypuvcym vsbdajgprp (fmkjudeawg )
Negative
29 May 2026
Cilta-cel
llrdlbvfki(clyeplgece) = uxuwovctgb vsbdajgprp (fmkjudeawg )
Phase 1/2
114
kijpdkmqpg(lsfrfskffa) = wenkxjjkrh xadwmjncfz (tdlbfkqdsq )
Positive
29 May 2026
kijpdkmqpg(lsfrfskffa) = rwslwyzlxm xadwmjncfz (tdlbfkqdsq )
Phase 2
50
wrnplfkydh(rgmuvljigc) = buiqphsuny klxqobekfh (uhczhhcfxe )
Positive
29 May 2026
wrnplfkydh(rgmuvljigc) = vdbqycsemf klxqobekfh (uhczhhcfxe )
Phase 2
30
oacoqapzsp(yfxextlmlf) = lupcqyralp idqpquevoa (ahirjuiajp )
Positive
12 May 2026
qdisaifbor(ghznmvsefn) = ixcykxuapk xelwlwzqkg (qshovctyru )
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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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