Blinatumomab
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.
Approved for relapsed and MRD-positive B-ALL; 2024 approval in consolidation for MRD-negative adults (E1910, OS benefit) and children (AALL1731). Continuous infusion because of a 2-hour half-life; subcutaneous formulation in development.
Blinatumomab is a tandem scFv (~55 kDa); intact IgG shown as reference.
1.One arm binds CD19 on the tumour cell
- Route
- Continuous IV infusion
- Schedule
- Adults: 9 µg/day days 1-7 then 28 µg/day to day 28, 14-day break; 42-day cycles; weight-based in children
- Dose modifications
- Interrupt for grade 3 CRS or neurotoxicity; dexamethasone premedication
- Monitoring
- Hospitalisation for first 9 days of cycle 1 and first 2 days of cycle 2; neurological exams; infection surveillance
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- Medicare
- Part B (clinician-administered)
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.
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- Amgen SupportPlus
- Amgen Safety Net Foundation
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
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.
- Appraised for
- Philadelphia-negative relapsed or refractory B-cell precursor ALL
- Notes
- MRD-positive B-ALL recommended in TA589 (2019). Front-line use (E1910) appraised later.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA450 · SMC advice: blinatumomab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 3 Dec 2014ApprovalUS
Accelerated approval, Ph-negative relapsed/refractory B-ALL: first BiTE source
- 11 Jul 2017ApprovalUS
Full approval including Ph+ ALL source
- 29 Mar 2018ApprovalUS
MRD-positive B-ALL: first approval based on MRD source
- 14 Jun 2024ApprovalUS
Consolidation in CD19+ Ph-negative B-ALL regardless of MRD (E1910) source
Approvals
| 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.
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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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.
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.
Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- ProductDasatinib
Shares BCR::ABL1 TKI + blinatumomab (chemotherapy-free Ph+ ALL), D-ALBA (GIMEMA LAL2116), Transplant-free Ph-positive ALL for MRD-negative adults, Ph-positive ALL.
- ProductPonatinib
Shares BCR::ABL1 TKI + blinatumomab (chemotherapy-free Ph+ ALL), Transplant-free Ph-positive ALL for MRD-negative adults, Ph-positive ALL, Philadelphia chromosome (Ph+, BCR::ABL1).
- TrialPhALLCON
Shares BCR::ABL1 TKI + blinatumomab (chemotherapy-free Ph+ ALL), Ph-positive ALL, Acute lymphoblastic leukaemia.
- TermMRD-negative complete remission
Shares Transplant-free Ph-positive ALL for MRD-negative adults, ECOG-ACRIN E1910, ECOG-ACRIN E1910: adding blinatumomab to chemotherapy for adults with B-cell ALL already in MRD-negative remission, Acute lymphoblastic leukaemia.
- ProductImatinib
Shares Hagop M. Kantarjian, Ph-positive ALL, Philadelphia chromosome (Ph+, BCR::ABL1), Leukaemia (tissue type).
- ProductAsciminib
Shares Ph-positive ALL, Philadelphia chromosome (Ph+, BCR::ABL1), Acute lymphoblastic leukaemia.
- TargetKMT2A (MLL) rearrangement
Shares Interfant-06, Menin inhibitors for infant KMT2A-rearranged ALL, Acute lymphoblastic leukaemia.
- TermB cell
Shares Leukaemia (tissue type), CD19, T-cell engagers (bispecific), Acute lymphoblastic leukaemia.