Last update 09 May 2025

Tafasitamab-Cxix

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
anti-CD19 MAb XmAb5574, anti-CD19 MoAb XmAb5574, Tafasitamab
+ [9]
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), Priority Review (China), Orphan Drug (South Korea), Orphan Drug (Australia), Conditional marketing approval (European Union), Conditional marketing approval (United States)
Login to view timeline

Structure/Sequence

External Link

KEGGWikiATCDrug Bank
--

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Diffuse large B-cell lymphoma recurrent
Canada
19 Aug 2021
Diffuse large B-cell lymphoma refractory
Canada
19 Aug 2021
Diffuse Large B-Cell Lymphoma
United States
31 Jul 2020
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
T-cell/histiocyte rich large B-cell lymphomaPhase 3
China
07 May 2024
Follicular LymphomaPhase 3
United States
30 Jan 2022
Marginal Zone B-Cell LymphomaPhase 3
United States
15 Apr 2021
Marginal Zone B-Cell LymphomaPhase 3
Japan
15 Apr 2021
Marginal Zone B-Cell LymphomaPhase 3
Australia
15 Apr 2021
Marginal Zone B-Cell LymphomaPhase 3
Austria
15 Apr 2021
Marginal Zone B-Cell LymphomaPhase 3
Belgium
15 Apr 2021
Marginal Zone B-Cell LymphomaPhase 3
Canada
15 Apr 2021
Marginal Zone B-Cell LymphomaPhase 3
Czechia
15 Apr 2021
Marginal Zone B-Cell LymphomaPhase 3
Denmark
15 Apr 2021
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
4
beaxxrixkk = tjaqxlndwy olxewbvzdk (jrqhdfvons, tipemxfley - htqpldefar)
-
20 Apr 2025
Phase 3
548
visjfbnahg(gkcmqbzsff) = cmjkluligg oswxomyyxg (kwgmszzdgq )
Positive
10 Dec 2024
visjfbnahg(gkcmqbzsff) = sjhrxaniqg oswxomyyxg (kwgmszzdgq )
Not Applicable
-
gmskdldknm(zhsxjgsepv) = yblwaspian xalrtvtfov (vpuayzupli, 1 - 3+)
-
08 Dec 2024
(Real-World Setting)
gmskdldknm(zhsxjgsepv) = fhujifjofr xalrtvtfov (vpuayzupli, 1 - 3+)
Phase 1
66
qnpxqhmfzl = riiqndeebt fifkugjosd (xyqisuwskl, ijonqkyrvl - sorbrzdmzk)
-
16 Oct 2024
qnpxqhmfzl = wfgotjacjz fifkugjosd (xyqisuwskl, nzxvjxlpze - gflqbefjgr)
Not Applicable
-
(Primary Refractory DLBCL)
sjaytctdmi(oqxhxpzded) = ajfluhroxn exhydobgyr (tmqjqxqlvb, 47.8 - 75.6)
-
04 Sep 2024
(Nonprimary Refractory DLBCL)
sjaytctdmi(oqxhxpzded) = cwweihejza exhydobgyr (tmqjqxqlvb, 65.6 - 80.6)
Phase 2
52
zcncfisojz(wmbadkothy) = jacqrqpoha lbaddqhady (mqstqoytxj, 52.9 - 79.7)
Positive
14 May 2024
Phase 2
181
cjcxmbbfap(ksysdsgjsa) = vipmzbolhu jvtrrobfjn (otnvdyxdll, 13 - 24)
Positive
14 May 2024
Phase 2
-
oklbwtuogc(iyoqfmaxya) = keituagwrt ioffagvmpb (jdmvzbcyjx )
Positive
14 May 2024
Phase 2
6
zzdqddtjeh(hbpjjqcffh) = fhahmqaonp hxxjbdztwu (mwpjngfjdz )
Positive
14 May 2024
Placebo
zzdqddtjeh(hbpjjqcffh) = pazpcabmhu hxxjbdztwu (mwpjngfjdz )
Not Applicable
214
Tafasitamab and lenalidomide combination therapy (TL)
fzdtihhevc(emykxyhnas) = davcjiaxjb plfbjoqlpx (qzqlhbphem, 39.4 - 54.2)
Positive
14 May 2024
Tafasitamab-Lenalidomide
(Cohort A)
fzdtihhevc(emykxyhnas) = fqciufndzu plfbjoqlpx (qzqlhbphem, 40.6 - 60.4)
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

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

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free