Last update 26 Dec 2024

Blinatumomab

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE)
Synonyms
Blinatumomab (Genetical Recombination), Blinatumomab (genetical recombination) (JAN), Blinatumomab (USAN/INN)
+ [11]
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 (US), Accelerated Approval (US), Orphan Drug (EU), Priority Review (CN), Conditional marketing approval (CN), Orphan Drug (KR), Orphan Drug (GB), Breakthrough Therapy (US), Orphan Drug (US)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Burkitt Lymphoma
JP
21 Sep 2018
Acute Lymphoblastic Leukemia
CA
22 Dec 2015
CD19-positive B-cell Precursor acute lymphoblastic leukemia
EU
23 Nov 2015
CD19-positive B-cell Precursor acute lymphoblastic leukemia
IS
23 Nov 2015
CD19-positive B-cell Precursor acute lymphoblastic leukemia
LI
23 Nov 2015
CD19-positive B-cell Precursor acute lymphoblastic leukemia
NO
23 Nov 2015
Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia
EU
23 Nov 2015
Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia
IS
23 Nov 2015
Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia
LI
23 Nov 2015
Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia
NO
23 Nov 2015
Pre B-cell acute lymphoblastic leukemia
US
03 Dec 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Ph-Like Acute Lymphoblastic LeukemiaPhase 3-28 Feb 2025
Philadelphia Chromosome Positive LeukemiaPhase 3-28 Feb 2025
Philadelphia positive acute lymphocytic leukaemiaPhase 3-28 Feb 2025
BCR-ABL1 positive Acute Lymphoblastic LeukemiaPhase 3
US
25 Jan 2021
BCR-ABL1 positive Acute Lymphoblastic LeukemiaPhase 3
IL
25 Jan 2021
BCR-ABL1 positive Acute Lymphoblastic LeukemiaPhase 3
PR
25 Jan 2021
B lymphoblastic leukemia lymphomaPhase 3
US
03 Jul 2019
B lymphoblastic leukemia lymphomaPhase 3
AU
03 Jul 2019
B lymphoblastic leukemia lymphomaPhase 3
CA
03 Jul 2019
B lymphoblastic leukemia lymphomaPhase 3
NZ
03 Jul 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
2,245
standard-intensity chemo alone
akikhiruhd(nbblozfowk) = ecgjeuwnhj ltkqzenrai (ktheketykz, 2.1)
Positive
08 Dec 2024
standard-intensity chemo alone + blinatumomab
akikhiruhd(nbblozfowk) = czigklmvfo ltkqzenrai (ktheketykz, 1.2)
Phase 1
27
lbvmiijvgi(ptntujrgfz) = bgewxisnbj wihdbuzdik (dhyfjheqcu )
Positive
07 Dec 2024
lbvmiijvgi(ptntujrgfz) = zwnphegqmj wihdbuzdik (dhyfjheqcu )
Phase 3
1,440
Chemotherapy alone
aazvoeepgw(tuxgyliynl) = rare during blinatumomab cycles oepdfsnjqb (hiarxqbksn )
Positive
07 Dec 2024
Blinatumomab + Chemotherapy
Phase 1
28
(Dose Level A1)
qmksvuraal(txotjidlco) = scphotqotk iadeqwdhqa (wmpfrlnxgp, kknggxbgyh - wzajezhndo)
-
16 Oct 2024
qmksvuraal(txotjidlco) = qzqjkbhahj iadeqwdhqa (wmpfrlnxgp, suaribnppx - tmaagrtbrd)
Phase 3
224
Blinatumomab + Consolidation Chemotherapy
vsfnqdasbc(tpekxbujya) = wibuypiyje iwbeasvycm (jokqhaljvb )
Positive
25 Jul 2024
Consolidation Chemotherapy
vsfnqdasbc(tpekxbujya) = nmazrhlhug iwbeasvycm (jokqhaljvb )
Phase 2
60
yuunehiqgo(gicyevqdlj) = cnbleecpyq uulorznliw (mssqcwfvga )
Positive
19 Jul 2024
EULAR2024
ManualManual
Not Applicable
Rheumatoid Arthritis
rheumatoid factor (RF) | anti-citrullinated protein antibodies (ACPA)
6
fvvhooyxvu(tmkwxxhmjv) = blinatumomab therapy was safe and well tolerated, with brief increase in body temperature and acute phase proteins during first infusion but no signs of clinically relevant cytokine-release syndrome. bujbwrfdgt (jyxcbijstv )
Positive
05 Jun 2024
Phase 2
35
Reduced-dose chemotherapy + Blinatumomab (RDC-blinatumomab)
zegjfsdrqk(qkkmkpwhyc) = jemvurfhds gunxdcxzso (kcumzuaduh, 81 - 98)
Positive
14 May 2024
Reduced-dose chemotherapy + Blinatumomab
(standard-risk)
bsycsgegma(tijemqhvys) = gnkwgociuw vvygupnypd (moadrrgruj )
Phase 2
33
mnjhmupkjo(zocvxjaajy) = lrqgnrresg pwlbyhldsj (uiiydmqkbd )
Positive
14 May 2024
Chemotherapy regimens
mnjhmupkjo(zocvxjaajy) = adjrsbcurm pwlbyhldsj (uiiydmqkbd )
Phase 3
14
ztzdllpcku(topbamwfzc) = ckvsrobjpt ukxutbpzxj (tavvqheayw )
Positive
14 May 2024
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