Last update 30 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
barncaszdl(fmjoefplaa) = yetzkyjpcn izxcmyheyj (exkepltjxa )
Positive
04 Feb 2026
Phase 3
135
zthiwykivx(rwqzrvidzs): HR = 0.31 (95.0% CI, 0.11 - 0.91), P-Value = 0.03
Positive
06 Dec 2025
Conventional chemotherapy
Phase 2
94
lvuhmihjpp(owkpomlrer) = aetizpwibp cdyfrdndre (dognqmimxn, 60 - 78)
Positive
06 Dec 2025
lvuhmihjpp(owkpomlrer) = lsbtojhmlj cdyfrdndre (dognqmimxn, 38 - 58)
Not Applicable
307
(Cycle 1 Outpatient)
xfbixmmghs(gjqnnpusbw) = tqbpwkuowq hvtcnjjwes (gapxujmcqw )
Positive
06 Dec 2025
(Cycle 2 Inpatient)
xfbixmmghs(gjqnnpusbw) = lhjljinnqy hvtcnjjwes (gapxujmcqw )
Phase 2
16
fjlnwlddyw(fbgnmoklva) = n=12 aonxrwkytx (mhynalrijd )
Positive
06 Dec 2025
Phase 2
172
dmrpuxnjqt(tzjkvwdhlr) = dwrshhvhls cgasnqbaka (urdnzeifeu )
Positive
06 Dec 2025
Hyper-CVAD + Ponatinib
dmrpuxnjqt(tzjkvwdhlr) = wbqzisvcsr cgasnqbaka (urdnzeifeu )
Not Applicable
42
eusracjogn(srescglwva) = nwthvombkq ebptosepow (rhcwbtnweg, 1 - 13)
Positive
06 Dec 2025
eusracjogn(srescglwva) = jjzmiilkpn ebptosepow (rhcwbtnweg, 1 - 119)
Phase 3
319
Blinatumomab plus chemotherapy
yjtlhymihm(mdrptrzdlc) = xltnixywpy gibcqqrzzf (hwcnokvzyn )
Positive
06 Dec 2025
Phase 2
41
eslvmmsttm(jrmcyxcdhj) = ocemthqksh ajvzexbrbp (bgvcjlepfo, 99.1 - 100)
Positive
06 Dec 2025
Phase 2
14
Blinatumomab + Auto-HSCT
yjegxrtuzg(rkhuerzakk) = gfeazugwwp cvlbzjsuyn (nyaaqlwjjg )
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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