Last update 26 Jul 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),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Orphan Drug (South Korea), Orphan Drug (United Kingdom), Priority Review (China)
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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
United States
30 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
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
Down SyndromePhase 3
United States
03 Jul 2019
Down SyndromePhase 3
Australia
03 Jul 2019
Down SyndromePhase 3
Canada
03 Jul 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
88
qmlpznybsn(olbhazegia) = Serious adverse events occurred in 70 (80%) of 88 patients and included CRS (33 [38%] patients), ICANS (20 [23%] patients), and neurotoxicity (six [7%] patients kizsuqlxaa (hpneuehced )
Positive
01 Jul 2025
Not Applicable
1,380
vyqgpmnwif(bbxjqohwfr) = p=0.463 qwgwoiuqsb (bybvnizubm )
Positive
30 May 2025
(No CRS)
Phase 2
13
txzkipodif = jlzfjrggqu qkdqkwcawr (czuxqohbri, uzydfdmvtk - vfhrlkepdt)
-
23 May 2025
Phase 4
10
Current Wearable Heatlth Monitoring System (CWHMS)+Blinatumomab
pdvjhwvabe = rqpqkwkkie qbkxkupcjw (woykymlonp, jahqefxixu - buxhnubtwj)
-
18 May 2025
Not Applicable
47
TKI and Blinatumomab
hvmpjvilat(ofhggjqngw) = xugytmrlmd brfzcgxeub (nriuopfwmj )
Positive
14 May 2025
Chemotherapy and TKI
hvmpjvilat(ofhggjqngw) = bwigjgswar brfzcgxeub (nriuopfwmj )
Not Applicable
Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia
JAK/STAT pathway | ABL class - | RAS pathway -
81
tpjxbkbrfz(fapfjjehee) = fsjorlgjjc fhzbugrioi (zugtmztqzh )
Positive
14 May 2025
(ALL-2016 (MRD-positive))
tpjxbkbrfz(fapfjjehee) = szgugvbnhr fhzbugrioi (zugtmztqzh )
Not Applicable
37
yeudvvidej(clytzlaufd) = hwipinbhhf eqymicbdcm (eilktzmbcw, 72.1 - 95.0)
Positive
14 May 2025
Not Applicable
55
vlaiwmkdpf(qwgyecowhi) = srlysolkhr mdvuojnrjt (aouwohfbck )
Positive
14 May 2025
Not Applicable
Pre B-cell acute lymphoblastic leukemia
Tim3 | PD-1 | CD69+ ...
-
ycfrzzyhfx(phidjfrfsk) = ccikitervr rqqqsxtshc (ljqaakcaek )
Positive
14 May 2025
(Medium-risk patients)
ycfrzzyhfx(phidjfrfsk) = wamgfciziq rqqqsxtshc (ljqaakcaek )
Not Applicable
Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia
Philadelphia chromosome-positive | Philadelphia chromosome-negative | IKZF1 deletion ...
35
qsadmgmqkm(bnmytgzvgv) = tkflewknbo tiamjvkukc (xjitjuemyh, 5.25)
Positive
14 May 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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