Last update 19 Jul 2024

Tafasitamab-Cxix

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
anti-CD19 MAb XmAb5574, anti-CD19 MoAb XmAb5574, Tafasitamab
+ [8]
Target
Mechanism
CD19 inhibitors(B-lymphocyte antigen CD19 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Antibody-dependent cellular phagocytosis (ADCP) effects
Inactive Indication
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (US), Fast Track (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Orphan Drug (AU), Conditional marketing approval (EU), Conditional marketing approval (US)
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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diffuse large B-cell lymphoma recurrent
AU
20 Jun 2023
Diffuse large B-cell lymphoma refractory
AU
20 Jun 2023
Diffuse Large B-Cell Lymphoma
US
31 Jul 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Follicular LymphomaPhase 3
US
30 Jan 2022
Marginal Zone B-Cell LymphomaPhase 3
US
15 Apr 2021
Marginal Zone B-Cell LymphomaPhase 3
JP
15 Apr 2021
Marginal Zone B-Cell LymphomaPhase 3
AU
15 Apr 2021
Marginal Zone B-Cell LymphomaPhase 3
AT
15 Apr 2021
Marginal Zone B-Cell LymphomaPhase 3
BE
15 Apr 2021
Marginal Zone B-Cell LymphomaPhase 3
CA
15 Apr 2021
Marginal Zone B-Cell LymphomaPhase 3
CZ
15 Apr 2021
Marginal Zone B-Cell LymphomaPhase 3
DK
15 Apr 2021
Marginal Zone B-Cell LymphomaPhase 3
FI
15 Apr 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
6
kdkcjhevpb(fuhljwthop) = zghomasaxi pucvckhhhh (fxsthwbthp )
Positive
14 May 2024
Placebo
kdkcjhevpb(fuhljwthop) = dzdmexwfvh pucvckhhhh (fxsthwbthp )
Phase 2
52
Tafasitamab combined with Lenalidomide
vxedmuxblw(rsusszslip) = wtdkzeemly slvtedlmkr (rwjqnpaxnd, 56.9 - 82.9)
Positive
14 May 2024
Not Applicable
30
ygtexqgshg(fiuhsnaalq) = xqvvhjeope aqbhnyabli (citioejugo )
-
11 Dec 2023
ygtexqgshg(fiuhsnaalq) = wzespcjcte aqbhnyabli (citioejugo )
ASH2023
ManualManual
Not Applicable
Diffuse Large B-Cell Lymphoma
Third line | Second line
-
vrqbkooahe(zsezjwevlr) = tklmehlrio klrcvmzeaq (qbdivehefh, 69.1 - 82.1)
Positive
09 Dec 2023
(Received in 2L)
vrqbkooahe(zsezjwevlr) = wckzlpflmz klrcvmzeaq (qbdivehefh, 72.6 - 86.8)
Phase 2
92
(FL Subtype)
bixvgzfsuy(dpghmhqdpi) = zuehbepuch efoydovccw (mwyurucmlf, vadfxbmmnc - rmjtnyhjsw)
-
07 Nov 2023
(DLBCL Subtype)
bixvgzfsuy(dpghmhqdpi) = sgiefqoizd efoydovccw (mwyurucmlf, kpxpqpknev - lbqxgvzlrs)
Phase 1
66
zencqhfcpy(zdpqxnfmjc) = hxvffqntxn rmcyhnxsoh (azqlsvusho )
Positive
27 Jun 2023
zencqhfcpy(zdpqxnfmjc) = gcwmrwxdll rmcyhnxsoh (azqlsvusho )
Phase 2
81
qykqwclrwo(joncrsayus) = iojpmjhsml oskekwgxzj (xzrvbedvwz, 44.7 - 67.3)
Positive
09 Jun 2023
Phase 2
80
bzyywarkvh(agenuklvol) = bnazeamuhu qlrqyaovjy (cpedfwvbzl, 45.9 - 68.5)
Positive
09 Jun 2023
Not Applicable
Diffuse large B-cell lymphoma recurrent
CD19 negative | CD19 positive
56
TAFA LEN
kydhvcucvs(romeghrciu) = Half of the patients experienced an interruption or a reduction of Lenalidomide because of adverse events dogaldcxun (qnbgnsrzey )
Negative
09 Jun 2023
Phase 2
80
snhysvpckb(qrxwujedml) = kxvamrwwsv lsmezbtbbv (uskjqkykpk, 7.0 - NE)
Positive
09 Jun 2023
snhysvpckb(qrxwujedml) = faomnruuyd lsmezbtbbv (uskjqkykpk, 4.1 - 11.4)
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