Drug Type Bispecific T-cell Engager (BiTE) |
Synonyms Blinatumomab (Genetical Recombination), Blinatumomab (genetical recombination) (JAN), Blinatumomab (USAN/INN) + [11] |
Target |
Mechanism CD19 inhibitors(B-lymphocyte antigen CD19 inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants) |
Therapeutic Areas |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (03 Dec 2014), |
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) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D09325 | Blinatumomab |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Ph-Like Acute Lymphoblastic Leukemia | Phase 3 | - | 28 Feb 2025 | |
Philadelphia Chromosome Positive Leukemia | Phase 3 | - | 28 Feb 2025 | |
Philadelphia positive acute lymphocytic leukaemia | Phase 3 | - | 28 Feb 2025 | |
BCR-ABL1 positive Acute Lymphoblastic Leukemia | Phase 3 | US | 25 Jan 2021 | |
BCR-ABL1 positive Acute Lymphoblastic Leukemia | Phase 3 | IL | 25 Jan 2021 | |
BCR-ABL1 positive Acute Lymphoblastic Leukemia | Phase 3 | PR | 25 Jan 2021 | |
B lymphoblastic leukemia lymphoma | Phase 3 | US | 03 Jul 2019 | |
B lymphoblastic leukemia lymphoma | Phase 3 | AU | 03 Jul 2019 | |
B lymphoblastic leukemia lymphoma | Phase 3 | CA | 03 Jul 2019 | |
B lymphoblastic leukemia lymphoma | Phase 3 | NZ | 03 Jul 2019 |
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) | ||||||
NCT04521231 (ASH2024) Manual | Phase 1 | 27 | lbvmiijvgi(ptntujrgfz) = bgewxisnbj wihdbuzdik (dhyfjheqcu ) View more | Positive | 07 Dec 2024 | ||
lbvmiijvgi(ptntujrgfz) = zwnphegqmj wihdbuzdik (dhyfjheqcu ) View more | |||||||
Phase 3 | Pre B-cell acute lymphoblastic leukemia CD19 | CD3 | 1,440 | Chemotherapy alone | aazvoeepgw(tuxgyliynl) = rare during blinatumomab cycles oepdfsnjqb (hiarxqbksn ) View more | Positive | 07 Dec 2024 | |
Blinatumomab + Chemotherapy | |||||||
Phase 1 | 28 | (Dose Level A1) | qmksvuraal(txotjidlco) = scphotqotk iadeqwdhqa (wmpfrlnxgp, kknggxbgyh - wzajezhndo) View more | - | 16 Oct 2024 | ||
(Dose Level B1) | qmksvuraal(txotjidlco) = qzqjkbhahj iadeqwdhqa (wmpfrlnxgp, suaribnppx - tmaagrtbrd) View more | ||||||
NCT02003222 (Pubmed) Manual | Phase 3 | 224 | Blinatumomab + Consolidation Chemotherapy | vsfnqdasbc(tpekxbujya) = wibuypiyje iwbeasvycm (jokqhaljvb ) View more | Positive | 25 Jul 2024 | |
Consolidation Chemotherapy | vsfnqdasbc(tpekxbujya) = nmazrhlhug iwbeasvycm (jokqhaljvb ) View more | ||||||
Phase 2 | 60 | yuunehiqgo(gicyevqdlj) = cnbleecpyq uulorznliw (mssqcwfvga ) View more | Positive | 19 Jul 2024 | |||
EULAR2024 Manual | 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 | |
NCT05557110 (EHA2024) Manual | Phase 2 | Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia First line | Induction | 35 | zegjfsdrqk(qkkmkpwhyc) = jemvurfhds gunxdcxzso (kcumzuaduh, 81 - 98) View more | Positive | 14 May 2024 | |
Reduced-dose chemotherapy + Blinatumomab (standard-risk) | bsycsgegma(tijemqhvys) = gnkwgociuw vvygupnypd (moadrrgruj ) | ||||||
Phase 2 | 33 | mnjhmupkjo(zocvxjaajy) = lrqgnrresg pwlbyhldsj (uiiydmqkbd ) View more | Positive | 14 May 2024 | |||
Chemotherapy regimens | mnjhmupkjo(zocvxjaajy) = adjrsbcurm pwlbyhldsj (uiiydmqkbd ) View more | ||||||
Phase 3 | 14 | Blinatumomab + LIC | ztzdllpcku(topbamwfzc) = ckvsrobjpt ukxutbpzxj (tavvqheayw ) View more | Positive | 14 May 2024 |