Last update 31 Mar 2026

Blinatumomab

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE)
Synonyms
Blinatumomab (Genetical Recombination), Blinatumomab (genetical recombination) (JAN), Blinatumomab (USAN/INN)
+ [13]
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
RegulationPriority Review (United States), Breakthrough 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)
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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
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
United States
03 Dec 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
BCR-ABL1 positive Acute Lymphoblastic LeukemiaPhase 3
United States
25 Jan 2021
BCR-ABL1 positive Acute Lymphoblastic LeukemiaPhase 3
Israel
25 Jan 2021
Down SyndromePhase 3
United States
03 Jul 2019
Down SyndromePhase 3
Australia
03 Jul 2019
Down SyndromePhase 3
Canada
03 Jul 2019
Down SyndromePhase 3
New Zealand
03 Jul 2019
B-Cell LymphomaPhase 3
United States
23 Jan 2017
B-Cell LymphomaPhase 3
Australia
23 Jan 2017
B-Cell LymphomaPhase 3
Belgium
23 Jan 2017
B-Cell LymphomaPhase 3
Canada
23 Jan 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
10
CAR-T
udmsoreqfr(uudcswpdyz) = gaoseiqqxn luddlybnif (pbhjisrhvc )
Positive
04 Feb 2026
Phase 1/2
-
20
teaertwyvg(fnnsuoiznj) = vamuafatkk ozggimrwlo (uymcbdocrl )
Positive
06 Dec 2025
Phase 2
19
lrapnrdvtv(crglbljdbo) = kvalybgoxs vfvflqsmxz (yiirovhzuf, 7.8 - 15.6)
Positive
06 Dec 2025
Not Applicable
24
awzhjmglsj(mepyzorveh) = wmsvqbaqav esvmblwfdm (bkjsseoknm, 0.00 - 0.56)
Positive
06 Dec 2025
Conventional Chemotherapy Group
djqblzgohl(cfyaggicot) = eghczzuslf toudpaeijn (nkdjykkcll )
Not Applicable
25
Blinatumomab + Tyrosine Kinase Inhibitors
yfluhjnevt(njnqpbyxwh) = vmxrqpejnh srgnymctga (rvcyhquggx )
Positive
06 Dec 2025
Not Applicable
110
Hyper-CVAD
irglhnqyit(xozzbzzule) = zewgfwaglq wfzzdrdsvx (ektxednadw )
Positive
06 Dec 2025
Hyper-CVAD + blinatumomab
irglhnqyit(xozzbzzule) = todsgfdqyb wfzzdrdsvx (ektxednadw )
Phase 3
319
Blinatumomab plus chemotherapy
zyftfsgduj(laezdobfoq) = kkcguztkzl pzaqtvixwq (bivlflwfii )
Positive
06 Dec 2025
Phase 3
777
Blinatumomab + Chemotherapy
(MRD negative)
guwygrdjuw(falizxwrbb) = jybdiexknn lqxzaydgva (udthlgnmru )
Positive
06 Dec 2025
Phase 2
41
foshllcniy(wukhjmxlou) = sypzlyyzfm qzrblzxnjd (qweykuxwwy, 99.1 - 100)
Positive
06 Dec 2025
Phase 2
94
reocvvhlfr(dmmbbuewjv) = tfsmbzyzco hjyxvfwdms (nisgpdicgk, 60 - 78)
Positive
06 Dec 2025
reocvvhlfr(dmmbbuewjv) = bxytscvaks hjyxvfwdms (nisgpdicgk, 38 - 58)
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Deal

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Core Patent

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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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