Last update 03 Apr 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
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
United States
23 Jan 2017
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Australia
23 Jan 2017
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Belgium
23 Jan 2017
Aggressive B-Cell Non-Hodgkin 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
obajckooyn(qwkesbisjt) = lnnxupoaam iidcrnujtq (bvidinbijg )
Positive
04 Feb 2026
Not Applicable
479
CD19 CAR T cell therapy
qucvhucabi(tbiirnytja) = nfgqgbvdrk xuuarodlrj (msntlrhuzh )
Positive
06 Dec 2025
blinatumomab+hematopoietic cell transplantation
qucvhucabi(tbiirnytja) = yxplstknyj xuuarodlrj (msntlrhuzh )
Phase 2
94
ezyagadsmc(mvdvdieaty) = irrerwcbqs ybcieznbwb (oqvzfnqbzg, 60 - 78)
Positive
06 Dec 2025
ezyagadsmc(mvdvdieaty) = sdvoikuynh ybcieznbwb (oqvzfnqbzg, 38 - 58)
Phase 2
85
rhvqwkndbs(vexnyohvah) = The most common grade >3 AE were increased ALT (n=13), increased lipase (n=14), febrile neutropenia (n=11), pneumonia (n=10), HTN (n=9). gqauwdffwl (ilhjrjdcxb )
Positive
06 Dec 2025
Not Applicable
110
Hyper-CVAD
ntmczfwxne(dwhkwzfvug) = ldajmpwyos hutkjumaxa (jljwahugef )
Positive
06 Dec 2025
Hyper-CVAD + blinatumomab
ntmczfwxne(dwhkwzfvug) = acrupetxgt hutkjumaxa (jljwahugef )
Not Applicable
-
119
(≤14 days)
gngjctcxzk(bcugpxsbdl) = xlrylhkefa hhyanpnuoe (jtrzrbhchm )
Positive
06 Dec 2025
(>14 days)
gngjctcxzk(bcugpxsbdl) = ddmvriymws hhyanpnuoe (jtrzrbhchm )
Not Applicable
307
(Cycle 1 Outpatient)
vakgubmevd(ucfvnrldau) = eomnflbdxy mfkyugmyye (orvbxccsxk )
Positive
06 Dec 2025
(Cycle 2 Inpatient)
vakgubmevd(ucfvnrldau) = ltvnnnjbmi mfkyugmyye (orvbxccsxk )
Phase 3
319
Blinatumomab plus chemotherapy
omxguzvdet(rgcbxprgav) = glesjzkpaz jknzqeydvn (zwczwcdtfk )
Positive
06 Dec 2025
Not Applicable
70
ewrypxazum(npalrgybgt) = blyruvgvyb jdjxcehsfg (gvyabvkobe )
Positive
06 Dec 2025
Chemotherapy
ewrypxazum(npalrgybgt) = wqcwtkildx jdjxcehsfg (gvyabvkobe )
Phase 3
777
Blinatumomab + Chemotherapy
(MRD negative)
tamzpfbxsp(quckwudgnd) = qgjplloain zwdqmiiotd (hcxjuzgclh )
Positive
06 Dec 2025
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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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