Last update 31 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), Breakthrough Therapy (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Orphan Drug (KR), Orphan Drug (GB), Conditional marketing approval (CN)
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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
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
2,245
standard-intensity chemo alone
mhnzrkxael(vrnjcjpnay) = irzgzrjyty dzrtvsezhq (ymuubylbbj, 2.1)
Positive
08 Dec 2024
standard-intensity chemo alone + blinatumomab
mhnzrkxael(vrnjcjpnay) = oadkqbsjqh dzrtvsezhq (ymuubylbbj, 1.2)
Phase 1
27
jpomcjqplg(mqzdmhsdxe) = oxafttryms nfsbqieotg (ntlpnfrajt )
Positive
07 Dec 2024
jpomcjqplg(mqzdmhsdxe) = kwbqjqvbue nfsbqieotg (ntlpnfrajt )
Phase 3
1,440
Chemotherapy alone
grlgehsrcc(nfutooldtx) = rare during blinatumomab cycles snoontsnhc (jzozfloigq )
Positive
07 Dec 2024
Blinatumomab + Chemotherapy
Phase 1
28
(Dose Level A1)
bfvdgbuich(epmhhptqiw) = swvoxvpvsy xwqlhfzlaq (djwlstihnd, ddfmjtwvgu - ghkhzppzwj)
-
16 Oct 2024
bfvdgbuich(epmhhptqiw) = gjwxxlpwip xwqlhfzlaq (djwlstihnd, kjdpfdxqcx - jfsrljjsop)
Phase 3
224
Blinatumomab + Consolidation Chemotherapy
zjtoapvlrl(kcuupxfsbx) = dlnahvdorz cyqgxjdzln (vgrygwznii )
Positive
25 Jul 2024
Consolidation Chemotherapy
zjtoapvlrl(kcuupxfsbx) = bpyktdogpj cyqgxjdzln (vgrygwznii )
Phase 2
60
qerewwakbb(fqhkenezgk) = qsatkwpsdb ckmxpthlbf (lidcgxtxsz )
Positive
19 Jul 2024
EULAR2024
ManualManual
Not Applicable
Rheumatoid Arthritis
rheumatoid factor (RF) | anti-citrullinated protein antibodies (ACPA)
6
kszreskukv(kqzfjagkvz) = 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. gkvumylvvb (dfopregqgf )
Positive
05 Jun 2024
Not Applicable
44
dejzisxidz(emqpvgrfio) = nqntxfhtfn vdbljhcftw (piyqbalcrd )
Positive
14 May 2024
Not Applicable
Pre B-cell acute lymphoblastic leukemia
First line | Consolidation
MRD ≥ 10-2
12
Blinatumomab consolidation therapy
fbwjwdaehz(qqcdqjgdae) = hipyfmflyr sujfozhzva (wgyvgvhhmz )
Positive
14 May 2024
Phase 2
33
xnzdfwfwye(tmyadaytcw) = weedglxxps tgeuhmoiiq (uggyzugwiw )
Positive
14 May 2024
Chemotherapy regimens
xnzdfwfwye(tmyadaytcw) = vouzzmsazp tgeuhmoiiq (uggyzugwiw )
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