Last update 23 May 2025

Blinatumomab

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE)
Synonyms
Blinatumomab (Genetical Recombination), Blinatumomab (genetical recombination) (JAN), Blinatumomab (USAN/INN)
+ [12]
Action
inhibitors, stimulants
Mechanism
CD19 inhibitors(B-lymphocyte antigen CD19 inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (03 Dec 2014),
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Conditional marketing approval (China), Orphan Drug (South Korea), Orphan Drug (United Kingdom), Priority Review (United States)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Recurrent B Acute Lymphoblastic Leukemia
Japan
21 Sep 2018
Refractory B Acute Lymphoblastic Leukemia
Japan
21 Sep 2018
Acute Lymphoblastic Leukemia
Canada
22 Dec 2015
CD19-positive B-cell Precursor acute lymphoblastic leukemia
European Union
23 Nov 2015
CD19-positive B-cell Precursor acute lymphoblastic leukemia
Iceland
23 Nov 2015
CD19-positive B-cell Precursor acute lymphoblastic leukemia
Liechtenstein
23 Nov 2015
CD19-positive B-cell Precursor acute lymphoblastic leukemia
Norway
23 Nov 2015
Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia
European Union
23 Nov 2015
Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia
Iceland
23 Nov 2015
Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia
Liechtenstein
23 Nov 2015
Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia
Norway
23 Nov 2015
Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia
Australia
09 Nov 2015
Philadelphia positive acute lymphocytic leukaemia
Australia
09 Nov 2015
Pre B-cell acute lymphoblastic leukemia
United States
03 Dec 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Ph-Like Acute Lymphoblastic LeukemiaPhase 3-29 May 2025
BCR-ABL1 positive Acute Lymphoblastic LeukemiaPhase 3
United States
25 Jan 2021
BCR-ABL1 positive Acute Lymphoblastic LeukemiaPhase 3
Israel
25 Jan 2021
BCR-ABL1 positive Acute Lymphoblastic LeukemiaPhase 3
Puerto Rico
25 Jan 2021
B lymphoblastic leukemia lymphomaPhase 3
United States
03 Jul 2019
B lymphoblastic leukemia lymphomaPhase 3
Australia
03 Jul 2019
B lymphoblastic leukemia lymphomaPhase 3
Canada
03 Jul 2019
B lymphoblastic leukemia lymphomaPhase 3
New Zealand
03 Jul 2019
B lymphoblastic leukemia lymphomaPhase 3
Puerto Rico
03 Jul 2019
Down SyndromePhase 3
United States
03 Jul 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
10
Current Wearable Heatlth Monitoring System (CWHMS)+blinatumomab
hdrrgwlayc = ituijupema yyrkycwjow (gbnazecoqu, hcclfvgckp - lcxbpyeykl)
-
18 May 2025
Phase 2
2
dvvoynpmfs = faoxxtcxgv vhwoqvaaft (gniyvztsxv, yagpzpvoxy - tuoptkqcsy)
-
13 May 2025
Phase 3
1,440
Blinatumomab + Chemotherapy
ipywudjnop(ahoxuwscct) = wppriewfro blveckqbmx (klxnlzstfq, 1.2)
Positive
27 Feb 2025
Chemotherapy alone
ipywudjnop(ahoxuwscct) = yduekvfufs blveckqbmx (klxnlzstfq, 2.1)
Phase 3
-
BLINCYTO® (blinatumomab) +multiphase consolidation chemotherapy
gjktuxzhru(ymrqjvvtuy) = wvjgrkjvsc ufkclhkpqc (tefmfvarnk )
Positive
29 Jan 2025
Chemotherapy alone
gjktuxzhru(ymrqjvvtuy) = drupyaxqjg ufkclhkpqc (tefmfvarnk )
Phase 3
2,245
standard-intensity chemo alone
cnvnyzfoix(yqebzjprjb) = ariybelmsr jhsexlkxpr (jhcofvcdnx, 2.1)
Positive
08 Dec 2024
standard-intensity chemo alone + blinatumomab
cnvnyzfoix(yqebzjprjb) = olvbranafn jhsexlkxpr (jhcofvcdnx, 1.2)
Not Applicable
-
Inotuzumab ozogamicin (InO)
eirzzxnhrq(igskkdjrzl) = 16 (53%) and 2 (7%) developed CRS of any grade and grade 3 to 4, respectively, and 4 (13%) and 1 (3%) developed immune effector cell-associated neurotoxicity syndrome of any grade and grade 3, respectively cltsrndfqx (uofjmviyys )
-
08 Dec 2024
Blinatumomab (Blina)
Phase 1
27
uwlfzwiuby(mpmmpuvkqq) = okkvrlmquo wajfyzqkdm (lbwosqwcbi )
Positive
07 Dec 2024
uwlfzwiuby(mpmmpuvkqq) = zsfoaeywjk wajfyzqkdm (lbwosqwcbi )
Phase 1
28
(Dose Level A1)
msoirmysxo(clvparzpkz) = ynzkqkrrig wbzvekuntn (yjzerkaizl, bwfckyhicv - cojwztpmxw)
-
16 Oct 2024
msoirmysxo(clvparzpkz) = iigqpmjhbp wbzvekuntn (yjzerkaizl, bkwhuminrn - pgxxnxjmwq)
Not Applicable
-
wkxvrcoray(ylchzykyvu) = One death occurred in a patient treated with dasatinib and blinatumomab hkhjnydinh (dygtfpuycq )
-
04 Sep 2024
Phase 2
22
Mini-Hyper-CVD-Inotuzumab-Blinatumomab
grhmwamuat(aepljaospb) = jxcddkugmc wtsnmgynky (svpligtofd )
Positive
04 Sep 2024
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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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