BLINCYTO® (blinatumomab) is indicated for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients one month and older with:
Philadelphia chromosome-negative disease in the consolidation phase of multiphase chemotherapy ... Read More
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The choice between these infusion duration options should be made by the treating healthcare professional, considering the frequency of the infusion bag changes and the weight of the patient.†
*Prepared with Bacteriostatic 0.9% Sodium Chloride Injection (containing 0.9% benzyl alcohol).
†Use the preservative-free preparations of BLINCYTO® where possible in neonates. When prescribing BLINCYTO® (with preservative) for neonatal patients, consider the combined daily metabolic load of benzyl alcohol from all sources including BLINCYTO® (with preservative), other products containing benzyl alcohol or other excipients (eg, ethanol, propylene glycol) which compete with benzyl alcohol for the same metabolic pathway. Serious adverse reactions, including fatal reactions and the “gasping syndrome,” have been reported in very low birth weight neonates born weighing less than 1500 g, and early preterm neonates who received intravenous drugs containing benzyl alcohol as a preservative.
Please see Indications in above "Indications" tray and full Important Safety Information, including BOXED WARNINGS, below.
Reference: BLINCYTO® (blinatumomab) prescribing information, Amgen.
MRD(+): The BLAST pivotal study
Study design: N=86, an open-label, single-arm phase 2 study of adult patients with MRD(+) B-cell precursor ALL who had received at least 3 chemotherapy blocks of standard ALL therapy, were in hematologic complete remission (defined as < 5% blasts in bone marrow, absolute neutrophil count > 1 Gi/L, platelets > 100 Gi/L), and had MRD at a level of ≥ 0.1% using an assay with a minimum sensitivity of 0.01%. Primary endpoint: 81% (n=70/86) of patients had no detectable MRD assessed after 1 treatment cycle with BLINCYTO®.* Select secondary endpoints: OS, hematologic RFS at 18 months, duration of hematologic remission.1,2
Primary endpoint: complete MRD response1,*
81%
(n=70/86)
of patients had no detectable MRD†
Percentage of patients who proceeded to allogeneic hematopoietic stem cell transplantation (HSCT)1
*Defined as the absence of detectable MRD confirmed in an assay with a minimum sensitivity of 0.01% for 6 patients and ≤ 0.005% for 80 patients. Undetectable MRD was achieved by 65 of 80 patients with an assay sensitivity of at least 0.005%.1
†Assessed after 1 treatment cycle.1
ALL, acute lymphoblastic leukemia; MRD, measurable or minimal residual disease.
Median OS in patients with vs without a complete MRD response3,‡
| Patient response | n | Median OS | 95% CI |
| MRD responders at cycle 1 | 84 | NR | 29.5–NR |
| MRD nonresponders at cycle 1 | 23 | 14.4 months | 3.8–32.3 |
†OS was evaluated in patients with Ph(–) B‐cell precursor ALL with less than 5% blasts at enrollment and includes 74 patients who received HSCT while in CCR after BLINCYTO®. Analyses of OS by complete MRD response after cycle 1 included 107 patients, of which patients with no central MRD assay (n=1) or inadequate MRD test sensitivity (n=2) were excluded.3
‡Patients in this population differ from the USPI population. Analysis includes additional patients: those who achieved CRh* and CRi and/or are in CR3.1,2,4,5
CCR, continuous complete remission; CI, confidence interval; CR3, third complete remission; CRh*, complete remission with partial hematologic recovery; CRi, complete remission with incomplete hematologic recovery; NE, not estimable; NR, not reached; OS, overall survival; Ph(–), Philadelphia chromosome–negative; USPI, United States Prescribing Information.
Relapse-free survival (RFS)§ in patients with vs without complete MRD response2,6,**,††
Median RFS‡‡ in patients§§ who were MRD(+) treated in first complete remission vs second complete remission1
†Patients in this population differ from the USPI population. Analysis includes the following additional patients: those who achieved CRh* and CRi, and/or are in CR3.1,2,4,5
‡Landmark analysis included patients in both the Key Secondary Full Analysis Set and the Primary Endpoint Analysis Set from the BLAST study and excludes patients with an event (death or relapse) or censored before day 45; patients without MRD results (n=1); or insufficient sensitivity of the assay (n=2).2
§Kaplan-Meier estimates with 2-sided 95% CIs were used to describe RFS; differences between subgroups were evaluated using log-rank test.2
**Of the patients in the Key Secondary Full Analysis Set, 67% (74 out of 110) underwent HSCT in continuous remission.2
††The median RFS was 23.6 months for MRD responders (n=70) vs 10.6 months (n=16) for nonresponders based on an exploratory analysis of the USPI population.5,‡
‡‡Relapse was defined as either hematological or extramedullary relapse, secondary leukemia, or death due to any cause; includes time after transplantation; Kaplan-Meier estimate.1
§§74% (45/61) of patients in first complete remission and 56% (14/25) of patients in second complete remission underwent HSCT.1
BLAST study design: A single-arm, phase 2 study of BLINCYTO® treatment for adult patients with MRD(+) B-cell precursor ALL1,2,4
Adults ≥ 18 years of age with B‑cell precursor ALL in hematologic first complete remission or second complete remission with MRD ≥ 0.1%*
Follow-up:
30 days
(safety);
24 months
plus
5-year survival follow-up
| Key inclusion criteria1 |
|---|
| Adults ≥ 18 years of age with B-cell precursor ALL in hematologic complete remission |
| Measurable residual disease (MRD)‡ level of ≥ 0.1% (molecular relapse or molecular failure)§ |
| < 5% blasts in bone marrow |
| ANC > 1 Gi/L |
| Platelets > 100 Gi/L |
| Key exclusion criteria4 |
| Prior HSCT |
| Presence of circulating blasts or current extramedullary disease |
| History of relevant CNS pathology or current relevant CNS pathology |
| Prior systemic cancer chemotherapy within 2 weeks or radiotherapy within 4 weeks |
Most patients were in first complete remission at baseline1
| Baseline characteristics of patients (N=86) | |
|---|---|
| Age | |
| Median, years (min, max) | 43 (18, 76) |
| ≥ 65 years, n (%) | 10 (12) |
| Males, n (%) | 50 (58) |
| Philadelphia chromosome disease status, n (%) | |
| Positive | 1 (1) |
| Negative | 85 (99) |
| Relapse history, n (%) | |
| In first complete remission | 61 (71) |
| In second complete remission | 25 (29) |
| Baseline MRD levels,* n (%) | |
| ≥ 10% | 7 (8) |
| ≥ 1% and < 10% | 34 (40) |
| ≥ 0.1% and < 1% | 45 (52) |
*As determined by an assay with a minimum sensitivity of 0.01%.1
†Defined as the absence of detectable MRD confirmed in an assay with minimum sensitivity of 0.01% for 6 patients and ≤ 0.005% for 80 patients. Undetectable MRD was achieved by 65 of 80 patients with an assay sensitivity of at least 0.005%.1
‡Also referred to as minimal residual disease.
§In an assay with a minimum sensitivity of 0.01%, MRD level of ≥ 0.1% after ≥ 3 intensive chemotherapy treatments.1
ANC, absolute neutrophil count; AYA, adolescent and young adult; CNS, central nervous system; IV, intravenous.
Blinatumomab is recommended by the National Comprehensive Cancer Network® (NCCN®) as a preferred therapy as part of frontline consolidation for AYA and adult patients with MRD(+) Ph(–) B-cell precursor ALL7
Blinatumomab is also recommended as part of frontline consolidation for MRD(+) Ph(+) B-cell precursor ALL7
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME
BLINCYTO® is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation.
The incidence of signs and symptoms consistent with ICANS in clinical trials was 7.5%. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. There is limited experience with BLINCYTO® in patients with active ALL in the central nervous system (CNS) or a history of neurologic events. Patients with a history or presence of clinically relevant CNS pathology were excluded from clinical studies. Patients with Down Syndrome may have a higher risk of seizures with BLINCYTO® therapy; consider seizure prophylaxis prior to initiation of BLINCYTO® for these patients.
Monitor patients for signs and symptoms of neurological toxicities, including ICANS, and interrupt or discontinue BLINCYTO® and/or treat with corticosteroids as outlined in the PI. Advise outpatients to contact their healthcare professional if they develop signs or symptoms of neurological toxicities.
Use the preservative-free preparations of BLINCYTO® where possible in neonates. When prescribing BLINCYTO® (with preservative) for neonatal patients, consider the combined daily metabolic load of benzyl alcohol from all sources including BLINCYTO® (with preservative), other products containing benzyl alcohol or other excipients (e.g., ethanol, propylene glycol) which compete with benzyl alcohol for the same metabolic pathway.
Monitor neonatal patients receiving BLINCYTO® (with preservative) for new or worsening metabolic acidosis. The minimum amount of benzyl alcohol at which serious adverse reactions may occur in neonates is not known. The BLINCYTO® 72-Hour bag (with preservative) and 96-Hour bag (with preservative) contain 2.5 mg of benzyl alcohol per mL, and the 7-Day bag (with preservative) contains 7.4 mg of benzyl alcohol per mL.
BLINCYTO® (blinatumomab) is indicated for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients one month and older with:
Please see BLINCYTO® full Prescribing Information, including BOXED WARNINGS.
BLINCYTO® is a registered trademark of Amgen Inc.
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME
References: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen. 2. Gökbuget N, Dombret H, Bonifacio M, et al. Blinatumomab for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukemia. Blood. 2018;131:1522-1531. 3. Gökbuget N, Zugmaier G, Dombret H, et al. Curative outcomes following blinatumomab in adults with minimal residual disease B-cell precursor acute lymphoblastic leukemia. Leuk Lymphoma. 2020;61:2665-2673. 4. Gökbuget N, Dombret H, Bonifacio M, et al. Blinatumomab for minimal residual disease in adults with B-precursor acute lymphoblastic leukemia. Blood. 2018;131(suppl):1522-1531. 5. Data on file, Amgen; 2018. 6. Food and Drug Administration. BLINCYTO® (blinatumomab) for minimal residual disease positive (MRD+) B-cell precursor acute lymphoblastic leukemia (ALL). https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM603411.pdf. Accessed April 2, 2025. 7. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia V.1.2025. ©National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed May 15, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 8. National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf. Accessed April 21, 2025.