Drug Type Bispecific T-cell Engager (BiTE) |
Synonyms Blinatumomab (Genetical Recombination), Blinatumomab (genetical recombination) (JAN), Blinatumomab (USAN/INN) + [13] |
Target |
Action inhibitors, stimulants |
Mechanism CD19 inhibitors(B-lymphocyte antigen CD19 inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License 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), Priority Review (China), Conditional marketing approval (China), Orphan Drug (South Korea), Orphan Drug (United Kingdom) |

| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D09325 | Blinatumomab |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| 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 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| BCR-ABL1 positive Acute Lymphoblastic Leukemia | Phase 3 | United States | 25 Jan 2021 | |
| BCR-ABL1 positive Acute Lymphoblastic Leukemia | Phase 3 | Israel | 25 Jan 2021 | |
| Down Syndrome | Phase 3 | United States | 03 Jul 2019 | |
| Down Syndrome | Phase 3 | Australia | 03 Jul 2019 | |
| Down Syndrome | Phase 3 | Canada | 03 Jul 2019 | |
| Down Syndrome | Phase 3 | New Zealand | 03 Jul 2019 | |
| Aggressive B-Cell Non-Hodgkin Lymphoma | Phase 3 | United States | 23 Jan 2017 | |
| Aggressive B-Cell Non-Hodgkin Lymphoma | Phase 3 | Australia | 23 Jan 2017 | |
| Aggressive B-Cell Non-Hodgkin Lymphoma | Phase 3 | Belgium | 23 Jan 2017 | |
| Aggressive B-Cell Non-Hodgkin Lymphoma | Phase 3 | Canada | 23 Jan 2017 |
Not Applicable | 10 | CAR-T | obajckooyn(qwkesbisjt) = lnnxupoaam iidcrnujtq (bvidinbijg ) View more | Positive | 04 Feb 2026 | ||
Not Applicable | 479 | CD19 CAR T cell therapy | qucvhucabi(tbiirnytja) = nfgqgbvdrk xuuarodlrj (msntlrhuzh ) View more | Positive | 06 Dec 2025 | ||
blinatumomab+hematopoietic cell transplantation | qucvhucabi(tbiirnytja) = yxplstknyj xuuarodlrj (msntlrhuzh ) View more | ||||||
Phase 2 | 94 | ezyagadsmc(mvdvdieaty) = irrerwcbqs ybcieznbwb (oqvzfnqbzg, 60 - 78) View more | Positive | 06 Dec 2025 | |||
ezyagadsmc(mvdvdieaty) = sdvoikuynh ybcieznbwb (oqvzfnqbzg, 38 - 58) | |||||||
Phase 2 | 85 | rhvqwkndbs(vexnyohvah) = The most common grade >3 AE were increased ALT (n=13), increased lipase (n=14), febrile neutropenia (n=11), pneumonia (n=10), HTN (n=9). gqauwdffwl (ilhjrjdcxb ) View more | Positive | 06 Dec 2025 | |||
Not Applicable | 110 | Hyper-CVAD | ntmczfwxne(dwhkwzfvug) = ldajmpwyos hutkjumaxa (jljwahugef ) View more | Positive | 06 Dec 2025 | ||
Hyper-CVAD + blinatumomab | ntmczfwxne(dwhkwzfvug) = acrupetxgt hutkjumaxa (jljwahugef ) View more | ||||||
Not Applicable | - | 119 | (≤14 days) | gngjctcxzk(bcugpxsbdl) = xlrylhkefa hhyanpnuoe (jtrzrbhchm ) View more | Positive | 06 Dec 2025 | |
(>14 days) | gngjctcxzk(bcugpxsbdl) = ddmvriymws hhyanpnuoe (jtrzrbhchm ) View more | ||||||
Not Applicable | 307 | (Cycle 1 Outpatient) | vakgubmevd(ucfvnrldau) = eomnflbdxy mfkyugmyye (orvbxccsxk ) View more | Positive | 06 Dec 2025 | ||
(Cycle 2 Inpatient) | vakgubmevd(ucfvnrldau) = ltvnnnjbmi mfkyugmyye (orvbxccsxk ) View more | ||||||
Phase 3 | Acute Lymphoblastic Leukemia CEBPA | CEBPB | 319 | Blinatumomab plus chemotherapy | omxguzvdet(rgcbxprgav) = glesjzkpaz jknzqeydvn (zwczwcdtfk ) View more | Positive | 06 Dec 2025 | |
Not Applicable | 70 | ewrypxazum(npalrgybgt) = blyruvgvyb jdjxcehsfg (gvyabvkobe ) View more | Positive | 06 Dec 2025 | |||
Chemotherapy | ewrypxazum(npalrgybgt) = wqcwtkildx jdjxcehsfg (gvyabvkobe ) View more | ||||||
Phase 3 | 777 | Blinatumomab + Chemotherapy (MRD negative) | tamzpfbxsp(quckwudgnd) = qgjplloain zwdqmiiotd (hcxjuzgclh ) View more | Positive | 06 Dec 2025 |






