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Blinatumomab was the first T-cell engager (2014), and is now given to children and adults with leukaemia even when in remission, because it improves survival.
Blinatumomab is a bispecific T-cell engager (BiTE) built from two tandem single-chain antibody fragments, one binding CD19 on B-lineage leukaemia cells and the other binding CD3 on T cells, so any T cell can be redirected to kill the leukaemia cell without MHC presentation. Its half-life is about 2 hours, so it is given by continuous intravenous infusion in 42-day cycles; a subcutaneous formulation is in development. Approved in 2014 as the first BiTE for relapsed or refractory B-ALL, it became the first drug approved on a minimal residual disease endpoint in 2018, and in 2024 was approved as consolidation for CD19-positive B-ALL regardless of MRD after E1910 showed an overall survival benefit in adults and AALL1731 in children. Neurological toxicity occurred in 65 percent of relapsed adults and cytokine release syndrome in 14 percent, so early cycle days are spent in hospital.
Backbone ribbon from PDB 1IGT. RCSB PDB 1IGT. The ribbon widens where the chain is folded into a regular pattern and narrows where it is a loose loop.
Blinatumomab is a tandem scFv (~55 kDa); intact IgG shown as reference.
1.One arm binds CD19 on the tumour cell
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Step-up dosing is often started in hospital (Part A) because of cytokine release syndrome monitoring, then continued in the outpatient setting. Continuous 28-day infusion via a portable pump; HCPCS J9039.
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE TA450 · SMC advice: blinatumomab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Philadelphia chromosome negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia
Accelerated approval, Ph-negative relapsed/refractory B-ALL: first BiTE source
Philadelphia chromosome negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia
Full approval including Ph+ ALL source
Treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children 1
MRD-positive B-ALL: first approval based on MRD source
Treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children 1
Confirmed: the accelerated approval of 2018 converted to traditional approval 5.2 years after it was granted. source
Consolidation in CD19+ Ph-negative B-ALL regardless of MRD (E1910) source
| Region | Year | Indication |
|---|---|---|
| US | 2014 | Relapsed/refractory B-ALL |
| US | 2024 | Consolidation in CD19+ B-ALL regardless of MRD |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Neurological toxicities | 65% | 13% |
| Pyrexia | 55% | 6% |
| Febrile neutropenia | 31% | 28% |
| Infections | 28% | 15% |
| Cytokine release syndrome | 14% | 3% |
| Infusion-related reactions | - | - |
| Headache | - | - |
Relapsed/refractory adult ALL. Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
Read for the class this product belongs to (bispecific t-cell engagers) unless the answer names the product. Population figures from the cohorts named, not a prediction for one person. Blank where no source gives a recovery figure.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | amgensupportplus.com |
| United Kingdom | NICE: recommended in Ph-negative relapsed/refractory B-ALL (TA450) and MRD-positive ALL (TA589) | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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AALL1731 brings immunotherapy into the front-line treatment of the commonest childhood cancer, in the group of children where most relapses were occurring despite good initial risk. Blinatumomab was approved for this use in 2024 and paediatric protocols worldwide are being amended. Whether it can allow less chemotherapy, and its effect on very low-risk children, are the next questions.
E1910 changed the standard of care for adult B-ALL: immunotherapy is now part of front-line consolidation even for patients with no detectable leukaemia, because MRD-negative by flow cytometry does not mean cured. It also demonstrated that a T-cell engager can improve overall survival in a curative setting. Chemotherapy-light or chemotherapy-free regimens built on blinatumomab and inotuzumab are the next step.
Blinatumomab belongs in the treatment of low-risk marrow relapse in children; isolated extramedullary relapse needs new approaches.
Blinatumomab after induction is now standard for KMT2A-rearranged infant ALL through the Interfant-21 protocol.
Blinatumomab consolidation is a safer bridge to transplant for children with higher-risk relapsed B-ALL and improved survival; it is the basis for using blinatumomab in place of chemotherapy blocks after relapse.
INO-VATE made inotuzumab a standard salvage therapy for adult ALL and a common route to transplant, and, with the TOWER trial of blinatumomab, moved adult ALL from chemotherapy-only salvage to immunotherapy. Both drugs have since been pulled into front-line regimens. The liver toxicity signal shaped how transplant conditioning is chosen after inotuzumab.
Query for this drug: (TITLE:"Blinatumomab" OR ABSTRACT:"Blinatumomab" OR TITLE:"Blincyto" OR ABSTRACT:"Blincyto") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Blinatumomab, not a curated reading list.
Shares BCR::ABL1 TKI + blinatumomab (chemotherapy-free Ph+ ALL), D-ALBA (GIMEMA LAL2116), Ph-positive ALL, Mixed-phenotype acute leukaemia.
Shares BCR::ABL1 TKI + blinatumomab (chemotherapy-free Ph+ ALL), Ph-positive ALL, Transplant-free Ph-positive ALL for MRD-negative adults, BCR::ABL1 kinase domain mutations (T315I and others).
Shares Transplant-free Ph-positive ALL for MRD-negative adults, B-ALL risk groups (NCI criteria, ETV6::RUNX1, hyperdiploidy, hypodiploidy, iAMP21, IKZF1, CNS status), Philadelphia chromosome-like acute lymphoblastic leukaemia (Ph-like or BCR::ABL1-like ALL), Standard-risk B-cell acute lymphoblastic leukaemia in children.
Shares CD19 expression (CD19-positive), Philadelphia chromosome-like acute lymphoblastic leukaemia (Ph-like or BCR::ABL1-like ALL), Standard-risk B-cell acute lymphoblastic leukaemia in children, Philadelphia chromosome-positive acute lymphoblastic leukaemia in children (Ph-positive ALL).
Shares Ph-positive ALL, Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL), BCR::ABL1 kinase domain mutations (T315I and others), Philadelphia chromosome (Ph+, BCR::ABL1).
Shares Standard-risk B-cell acute lymphoblastic leukaemia in children, Adolescent and young adult cancers (ages 15 to 39), Philadelphia chromosome-positive acute lymphoblastic leukaemia in children (Ph-positive ALL), Infant acute lymphoblastic leukaemia (KMT2A-rearranged, under one year).
Shares Stephen P. Hunger, Hagop M. Kantarjian, Ph-positive ALL, Mixed-phenotype acute leukaemia.
Shares INO-VATE: inotuzumab ozogamicin, a CD22 antibody-drug conjugate, versus chemotherapy for relapsed adult B-cell ALL, Standard-risk B-cell acute lymphoblastic leukaemia in children, Philadelphia chromosome-positive acute lymphoblastic leukaemia in children (Ph-positive ALL), High-risk acute lymphoblastic leukaemia in children (high-risk B-ALL and T-ALL).