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.
Frontline consolidation phase: COG AALL1731
E1910, the study in adult patients with Ph(–) B-cell precursor ALL in frontline consolidation: A multinational, randomized, controlled, phase 3 trial of BLINCYTO® alternating with chemotherapy vs chemotherapy alone in frontline consolidation in 224 newly diagnosed patients aged 30–70 years with Ph(–) B-cell precursor ALL. OS was calculated from time of randomization until death due to any cause.1,2 3-year KM estimates for OS (primary endpoint) were 84.8% in the BLINCYTO® arm (n=112) vs 69.0% in the chemotherapy only arm (n=112); HR: 0.42 (95% CI: 0.24–0.75);* P = 0.003 (the stratified log-rank test). Median follow-up was 3.6 years in both arms.1 5-year KM estimates for OS were 82.4% in the BLINCYTO® arm (n=112) vs 62.5% in the chemotherapy only arm (n=112); HR: 0.44 (95% Cl: 0.25–0.76).1,†
COG AALL1731 study design: An international, randomized, controlled, phase 3 trial of BLINCYTO® alternating with chemotherapy vs chemotherapy alone in the frontline consolidation phase among 1,440 pediatric patients aged 1 to < 10 years with newly diagnosed Ph(–) NCI standard risk (SR) B-cell precursor ALL who have average or higher risk features.3,‡ 3-year DFS (primary endpoint) was 96.0% in the BLINCYTO® arm (n=718) vs 87.9% in the chemotherapy only arm (n=722); HR: 0.39 (95% CI: 0.24–0.64);§ P < 0.0001.3,4 Median follow-up was 2.5 years. Select secondary endpoints: OS, CIR.3
*The hazard ratio estimates are obtained from a stratified Cox regression model at the third interim analysis.1
†In a later analysis with a median follow-up of 4.5 years.1
‡SR-Favorable was defined as having all of the following: Favorable genetics (ETV6::RUNX1 fusion or double trisomies of chromosomes 4 and 10), CNS1/2, peripheral blood MRD < 1% at induction day 8, and bone marrow MRD < 0.01% at end of induction. SR-High was defined as having one or more of the following: Unfavorable genetics (iAMP21, KMT2A rearrangement, hypodiploidy (< 44 chromosomes and/or DNA index < 0.81), or t(17;19)(q21-q22;p13.3) or resultant E2A::HLF fusion transcript), end of induction MRD ≥ 0.1% and double trisomies of chromosomes 4 and 10, end of induction bone marrow MRD ≥ 0.01% and not double trisomies of chromosomes 4 and 10, and/or neutral genetics and CNS2. SR-Average was defined as not being SR-Favorable or SR-High.3,5
§The hazard ratio is > 1 for approximately 2 months post randomization, after which it crosses to < 1 for the duration of the follow-up period, with evidence of increasing effect over time.5
In the overall cohort, 3-year OS was 98.4% in the BLINCYTO® arm (n=718) vs 97.1% in the chemotherapy only arm (n=722)3
*DFS was defined as the time from randomization to a first event (relapse, a second malignant neoplasm, or death), with data censoring at the date of the last contact.3
†The hazard ratio is > 1 for approximately 2 months post randomization, after which it crosses to < 1 for the duration of the follow-up period, with evidence of increasing effect over time.5
‡Relapse, second malignant neoplasm, or death.3
ALL, acute lymphoblastic leukemia; AYA, adolescent and young adult; CI, confidence interval; CNS, central nervous system; COG, Children's Oncology Group; DFS, disease-free survival; HR, hazard ratio; KM, Kaplan-Meier; MRD, measurable or minimal residual disease; NCI, National Cancer Institute; OS, overall survival; Ph(–), Philadelphia chromosome–negative; SR, standard risk.
*Cumulative incidence of relapse is the estimated incidence of relapse over time.6
COG AALL1731 study design: An international, randomized, controlled, phase 3 trial of BLINCYTO® alternating with chemotherapy vs chemotherapy alone in the frontline consolidation phase among 1,440 pediatric patients aged 1 to < 10 years with newly diagnosed Ph(–) NCI standard risk (SR) B-cell precursor ALL.3
Treatment arms:5
*SR-Favorable was defined as having all of the following: Favorable genetics (ETV6::RUNX1 fusion or double trisomies of chromosomes 4 and 10), CNS1/2, peripheral blood MRD < 1% at induction day 8, and bone marrow MRD < 0.01% at end of induction. SR-High was defined as having one or more of the following: Unfavorable genetics (iAMP21, KMT2A rearrangement, hypodiploidy (< 44 chromosomes and/or DNA index < 0.81), or t(17;19)(q21-q22;p13.3) or resultant E2A::HLF fusion transcript), end of induction MRD ≥ 0.1% and double trisomies of chromosomes 4 and 10, end of induction bone marrow MRD ≥ 0.01% and not double trisomies of chromosomes 4 and 10, and/or neutral genetics and CNS2. SR-Average was defined as not being SR-Favorable or SR-High.3,5
†Does not include patients who had undetectable HTS MRD at the end of induction.3
‡Does not include patients who had MRD between 0.1% and 1% at the end of consolidation.3
§BLINCYTO® was administered as a continuous IV infusion at 15 mcg/m2/day for 28 days.5
| Key inclusion criteria3 |
|---|
| Pediatric patients aged 1 to < 10 years at diagnosis |
| Newly diagnosed Ph(–) SR B-cell precursor ALL |
| WBC count < 50,000/μL |
| Key exclusion criteria7 |
| Secondary ALL after treatment of prior malignancy with chemotherapy |
| Non-DS B-cell precursor ALL with CNS3 leukemia |
| Non-DS B-cell precursor ALL with testicular leukemia |
Demographics and baseline characteristics3,**
| Characteristic | SR-Average | SR-High | ||
|---|---|---|---|---|
| BLINCYTO® + chemotherapy arm (n=417) |
Chemotherapy only arm (n=418) |
BLINCYTO® + chemotherapy arm (n=301) |
Chemotherapy only arm (n=304) |
|
| Age | ||||
| Median, years (min, max) | 4.0 (1.0–9.9) | 4.3 (1.0–10.0) | 4.6 (1.0–10.0) | 4.2 (1.1–9.9) |
| Sex, n (%) | ||||
| Male | 210 (50.4) | 223 (53.3) | 158 (52.5) | 167 (54.9) |
| Race/ethnicity, n (%) | ||||
| Hispanic | 100 (24.0) | 104 (24.9) | 84 (27.9) | 84 (27.6) |
| Non-Hispanic Asian | 20 (4.8) | 19 (4.5) | 13 (4.3) | 10 (3.3) |
| Non-Hispanic Black | 26 (6.2) | 20 (4.8) | 16 (5.3) | 18 (5.9) |
| Non-Hispanic White | 217 (52.0) | 213 (51.0) | 156 (51.8) | 140 (46.1) |
| Other/Unknown | 54 (12.9) | 62 (14.8) | 32 (10.6) | 52 (17.1) |
| Down syndrome, n (%) | ||||
| No | 401 (96.2) | 402 (96.2) | 301 (100.0) | 304 (100.0) |
| Yes | 16 (3.8) | 16 (3.8) | - | - |
| Median WBC, x 109/liter (range) | 7.7 (0.3–49.7) | 7.5 (0.0–49.7) | 8.8 (0.4–47.8) | 7.4 (0.6–49.8) |
| CNS status, n (%)†† | ||||
| CNS1 | 399 (95.7) | 407 (97.4) | 242 (80.4) | 245 (80.6) |
| CNS2 | 18 (4.3) | 11 (2.6) | 59 (19.6) | 59 (19.4) |
| Cytogenetics, n (%) | ||||
| Favorable | 127 (30.5) | 114 (27.3) | 72 (23.9) | 96 (31.6) |
| Neutral | 290 (69.5) | 304 (72.7) | 165 (54.8) | 148 (48.7) |
| Unfavorable | - | - | 64 (21.3) | 60 (19.7) |
**Percentages may not total 100 due to rounding.3
††CNS1 defined as no leukemic blasts per cytologic evaluation. CNS2 defined as < 5 white cells per microliter and presence of blasts or traumatic lumbar puncture with presence of blasts per cytologic evaluation but absence of blasts per means of Steinherz–Bleyer algorithm.3
DS, Down syndrome; HTS, high-throughput sequencing; IV, intravenous; WBC, white blood cell count.
Blinatumomab is recommended by the National Comprehensive Cancer Network® (NCCN®) as part of the frontline consolidation phase for pediatric patients with Ph(–) B-cell precursor ALL regardless of MRD status8
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. Litzow MR, Sun Z, Mattison RJ, et al. Blinatumomab for MRD-negative acute lymphoblastic leukemia in adults. N Engl J Med. 2024;391:320-333. 3. Gupta S, Rau RE, Kairalla JA, et al. Blinatumomab in standard-risk B-cell acute lymphoblastic leukemia in children. N Engl J Med. Published online December 7, 2024. doi:10.1056/NEJMoa2411680. 4. Gupta S, Rau RE, Kairalla JA, et al. Blinatumomab in standard-risk B-cell acute lymphoblastic leukemia in children. N Engl J Med. Published online December 7, 2024 (suppl). doi:10.1056/NEJMoa2411680. 5. Rau R, Gupta S, Kairalla J, et al. Blinatumomab added to chemotherapy improves disease-free survival in newly diagnosed NCI standard risk pediatric B-acute lymphoblastic leukemia: Results from Children’s Oncology Group Study AALL1731. Presented at: 66th ASH Annual Meeting and Exposition; December 7–10, 2024; San Diego, CA. 6. Brazauskas R, Eapen M, Wang T. Endpoint selection and evaluation in hematology studies. Best Pract Res Clin Haematol. 2023;36:101479. 7. Gupta S, Rau RE, Kairalla JA, et al. Blinatumomab in standard-risk B-cell acute lymphoblastic leukemia in children. N Engl J Med. Published online December 7, 2024 (protocol). doi:10.1056/NEJMoa2411680. 8. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Pediatric Acute Lymphoblastic Leukemia V.3.2025. ©National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed April 21, 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.