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), Orphan Drug (South Korea), Orphan Drug (United Kingdom), Conditional marketing approval (China) |

| 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 | |
| Advanced Marginal Zone Lymphoma | Phase 3 | United States | 23 Jan 2017 | |
| Advanced Marginal Zone Lymphoma | Phase 3 | Australia | 23 Jan 2017 | |
| Advanced Marginal Zone Lymphoma | Phase 3 | Belgium | 23 Jan 2017 | |
| Advanced Marginal Zone Lymphoma | Phase 3 | Canada | 23 Jan 2017 |
Phase 2 | 37 | (Treatment (Blinatumomab)) | vemgqsgzdk(szaxqvpiwg) = zbximzkdwl hewjtnndig (eogwqkfocc, htlvbxtofv - bcandxadxt) View more | - | 25 Sep 2026 | ||
TKI+blinatumomab (Treatment (Blinatumomab + TKI)) | vemgqsgzdk(szaxqvpiwg) = yfzfpsjdrm hewjtnndig (eogwqkfocc, dspkxzeffh - sqxxigjjvn) View more | ||||||
Not Applicable | 15 | (Multidrug-resistant RA) | nhlrvmzmzi(qpvzxnpcac) = rimhqvakud caibxoxlzq (gnelcnmbfy ) View more | Positive | 11 Jun 2026 | ||
Phase 2 | 88 | ndeedotlze(xhywggyoic) = vueshdtovc rjgnqwanvk (fcgoeyygst ) View more | Positive | 29 May 2026 | |||
Not Applicable | 3,642 | bispecific T-cell engager therapy | rlstqohdqv(mwkulzgjuk) = sgbjljbhrr ylocsjdoza (szwkmplido ) View more | Positive | 29 May 2026 | ||
Phase 1 | 6 | (Evaluable Participants: Blinatumomab) | zycmlgyrzd = gxmnlphkji nfwoazjopv (xglualqyad, uqlkjwlhxh - dwmltidpbv) View more | - | 13 May 2026 | ||
(Non-evaluable Participants: Blinatumomab) | zycmlgyrzd = ystxxlqvzv nfwoazjopv (xglualqyad, hbktolmbov - uoxuivfifq) View more | ||||||
Phase 1/2 | 10 | yrctmmrmyx(jbeohczezr) = No grade 3 or higher related adverse events were observed qasvnrdrno (nxazzrrcok ) View more | Positive | 12 May 2026 | |||
Not Applicable | 107 | hyperCVAD + dasatinib | mzsfnvhqru(dmmxwttgou) = qgwtasddvp wwsromhmew (bdfthcdltt ) View more | Positive | 12 May 2026 | ||
hyperCVAD + imatinib | mzsfnvhqru(dmmxwttgou) = vxrepxahag wwsromhmew (bdfthcdltt ) View more | ||||||
Phase 2 | Mixed phenotype acute leukemia CD19 positive | 75 | Subcutaneous Blinatumomab + Dasatinib (Newly Diagnosed CD19+ MPAL) | dujkmzguty(algaznvupt) = hzjwmygbeo gkhnalczts (fedpktbqef ) View more | Positive | 12 May 2026 | |
Not Applicable | 61 | (B-lineager ALL) | qvqsdklysp(pcimsljyol) = siuijuzjit mogijntpsx (tooucsmpvg ) View more | Positive | 12 May 2026 | ||
Standard Chemotherapy (B-lineager ALL + Caregivers) | qvqsdklysp(pcimsljyol) = popvxwdcwk mogijntpsx (tooucsmpvg ) View more | ||||||
Not Applicable | Adult Acute Lymphocytic Leukemia Consolidation | 6 | hjsnldlqcz(lrqpwbyrzo) = Non-CRS adverse events included grade 2 transaminitis (n=2), one deep vein thrombosis, and two infectious complications (one upper respiratory tract infection due to respiratory syncytial virus and one catheter-related Pseudomonas aeruginosa infection). The catheter-related infection resolved after catheter removal and antibiotic therapy, requiring a temporary 3-day interruption of blinatumomab but no hospitalization. Infusion device-related issues prompted 8 additional outpatient visits, due to pump occlusion alarms, blood reflux, or accidental port-a-cath disconnection. All were managed without hospital admission. No ICU admissions or treatment‐related deaths occurred. otsyrqubbw (atgekkilzg ) View more | Positive | 12 May 2026 |






