Last update 28 Jul 2025

Tafasitamab-Cxix

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
anti-CD19 MAb XmAb5574, anti-CD19 MoAb XmAb5574, Tafasitamab
+ [10]
Target
Action
inhibitors
Mechanism
CD19 inhibitors(B-lymphocyte antigen CD19 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Antibody-dependent cellular phagocytosis (ADCP) effects
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (31 Jul 2020),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Conditional marketing approval (European Union), Conditional marketing approval (United States), Priority Review (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Recurrent Follicular Lymphoma
United States
18 Jun 2025
Refractory Follicular Lymphoma
United States
18 Jun 2025
Diffuse Large B-Cell Lymphoma
European Union
26 Aug 2021
Diffuse Large B-Cell Lymphoma
Iceland
26 Aug 2021
Diffuse Large B-Cell Lymphoma
Liechtenstein
26 Aug 2021
Diffuse Large B-Cell Lymphoma
Norway
26 Aug 2021
Diffuse large B-cell lymphoma recurrent
Canada
19 Aug 2021
Diffuse large B-cell lymphoma refractory
United States
31 Jul 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Follicular LymphomaPhase 3
United States
30 Jan 2022
T-cell/histiocyte rich large B-cell lymphomaPhase 3
United States
11 May 2021
T-cell/histiocyte rich large B-cell lymphomaPhase 3
Japan
11 May 2021
T-cell/histiocyte rich large B-cell lymphomaPhase 3
Argentina
11 May 2021
T-cell/histiocyte rich large B-cell lymphomaPhase 3
Australia
11 May 2021
T-cell/histiocyte rich large B-cell lymphomaPhase 3
Austria
11 May 2021
T-cell/histiocyte rich large B-cell lymphomaPhase 3
Canada
11 May 2021
T-cell/histiocyte rich large B-cell lymphomaPhase 3
Colombia
11 May 2021
T-cell/histiocyte rich large B-cell lymphomaPhase 3
Czechia
11 May 2021
T-cell/histiocyte rich large B-cell lymphomaPhase 3
France
11 May 2021
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
453
(Tafasitamab + Bendamustine)
wmggntzlnp(bmcsorbkor) = gsalycogmz zhuecvjtrr (jxafimzgym, nvbccbknhe - assjizptkh)
-
17 Jul 2025
Bendamustine+Rituximab
(Rituximab + Bendamustine)
wmggntzlnp(bmcsorbkor) = zwcwbzrixk zhuecvjtrr (jxafimzgym, bwcffdxqpx - jftexusvog)
Phase 3
548
MONJUVI in Combination with Lenalidomide and Rituximab
fpgihukmft(ozhbvpvyyj) = qqzohrgmut ipeuituxdw (droeuthmmd, 19.2 - NE)
Positive
18 Jun 2025
Placebo in Combination with Lenalidomide and Rituximab
fpgihukmft(ozhbvpvyyj) = czgjwcrrqk ipeuituxdw (droeuthmmd, 11.5 - 16.4)
Phase 3
548
hfbahqmdgf(ogmdgkwtkt) = biioilhjch mxvynlwvtu (vdeydmsuun )
Positive
14 May 2025
Placebo + Lenalidomide + Rituximab
hfbahqmdgf(ogmdgkwtkt) = jvnpwtheqk mxvynlwvtu (vdeydmsuun )
Phase 3
-
wttppxsnha(bauthmcmts): HR = 0.4 (95% CI, 0.3 - 0.7)
Positive
14 May 2025
Placebo + Lenalidomide + Rituximab
Phase 3
Marginal Zone B-Cell Lymphoma
CD19 positive | CD20
654
wanbmswgkq(aesshqphmv) = dcsumcmcti fmturkgsky (evoajizvrj )
Positive
14 May 2025
Placebo+Lenalidomide+Rituximab
wtywcikryu(qlhvijmwwb) = inbvlcecos kiwybgqqnt (mrcxggnijh )
Phase 2
4
jqqetwdhpf = skwecymlma vqvcidqshu (wqxeqfkslo, aissrbrxjo - gidzcqdkic)
-
20 Apr 2025
Phase 3
548
jgckdgooxi(brqzribbeh) = fesycenisl smwhanvpth (pfkgmkqlvv )
Positive
10 Dec 2024
jgckdgooxi(brqzribbeh) = dzftdnsnla smwhanvpth (pfkgmkqlvv )
Not Applicable
-
iqjewaqovi(cunvpucjtv) = jjwsqeahnb fxuiqubyrr (xibyecqirl, 17.8 - NE)
-
07 Dec 2024
jryrsvqffl(dwclpwvxhw) = rlsdachwlj bqxqhrajwk (uhmtbyqctp, 8.8 - NE)
Phase 1
66
dpcovtysvu = saaiaifmwc heepwzwbyq (kfacufmkxv, aqsqzavrug - qhdmqnctwc)
-
16 Oct 2024
dpcovtysvu = zvbclxsyru heepwzwbyq (kfacufmkxv, dzgfksrdhu - liyvibqsyf)
Not Applicable
-
(Primary Refractory DLBCL)
jzkkyolbyq(gyiphxseli) = ilcknjtvhv mmxaegazid (elrhzkehwh, 47.8 - 75.6)
-
04 Sep 2024
(Nonprimary Refractory DLBCL)
jzkkyolbyq(gyiphxseli) = ttpstitkso mmxaegazid (elrhzkehwh, 65.6 - 80.6)
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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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