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Indications

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 

Minimal residual disease (MRD) greater than or equal to 0.1% in first or second complete remission

Relapsed or refractory disease

Important Safety Information Prescribing Information Medication Guide Indications Patient Site Connect with a BLINCYTO® rep

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NOW AVAILABLEBLINCYTO® offers 72- and 96-hour* infusion durations—offering more flexibility for you and your patients

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.

BLINCYTO® (blinatumomab) logo

R/R Ph(+): ALCANTARA

Study design: BLINCYTO® single-agent immunotherapy was evaluated in an open-label, single-arm, multicenter phase 2 study (N=45) in adult patients with R/R Ph(+) B-cell precursor ALL who progressed after, or were intolerant to second- or later-generation TKI therapy and were intolerant or refractory to imatinib. Primary endpoint was CR/CRh* rate within the first 2 treatment cycles: 36% (n=16/45; 95% CI: 22–51).1,2 Selected secondary endpoints: MRD response rate during the first two cycles of treatment, RFS, OS, HSCT after BLINCYTO®-induced remission.1,2

BLINCYTO® is an effective treatment for R/R Ph(+) B-cell precursor ALL1

CR/CRh* was achieved for about a third of patients1

Primary endpoint: CR/CRh* rate within the first 2 treatment cycles1,2

assets-efficacy-adult-ph-36-bar-chart
AdultPh36BarChart Mobile

CR was defined as ≤ 5% blasts in the BM, no evidence of disease, and full recovery of peripheral blood counts (platelets > 100,000/mcL and ANC > 1,000/mcL).1

CRh* was defined as ≤ 5% blasts in the BM, no evidence of disease, and partial recovery of peripheral blood counts (platelets > 50,000/mcL and ANC > 500/mcL).1

Consistent response across subgroups1,2

40%

(n=4/10)

CR among patients with T315I mutation†

47%

(n=8/17)

CR/CRh* rate among patients treated with
≥ 3 prior TKIs†

35%

(n=8/23)

CR/CRh* rate among patients who had received prior
ponatinib therapy‡

  • 31% of responders (n=5/16) proceeded to HSCT1

†CR/CRh* in these subgroups was a prespecified analysis in ALCANTARA; however, the CR/CRh* efficacy in these subgroups was not a study objective and the study was not powered to assess CR/CRh* efficacy in these subgroups.3

‡Response in this subgroup is a post hoc analysis in ALCANTARA, thus the efficacy in this subgroup was not a study objective and the study was not powered to assess efficacy in this subgroup.3

ALL, acute lymphoblastic leukemia; ANC, absolute neutrophil count; BM, bone marrow; CI, confidence interval; CR, complete remission; CRh*, complete remission with partial hematologic recovery; HSCT, allogeneic hematopoietic stem cell transplantation; Ph(+), Philadelphia chromosome–positive; R/R, relapsed or refractory; TKI, tyrosine kinase inhibitor.

The majority of patients who achieved CR/CRh* with BLINCYTO® had a complete MRD response1,2

88%

(n=14/16)

of patients with CR/CRh* were MRD negative within
the first 2 treatment cycles1,2

  • MRD response was defined as MRD1 by PCR < 1 x 10-4
  • All patients with the T315I mutation who achieved CR/CRh* (n=4/10) were MRD negative within the first 2 treatment cycles2

MRD, measurable or minimal residual disease; PCR, polymerase chain reaction.

ALCANTARA study design and baseline characteristics of patients

ALCANTARA study design: BLINCYTO® single-agent immunotherapy was evaluated in an open-label, single-arm, multicenter phase 2 study (N=45) in adult patients with R/R Ph(+) B-cell precursor ALL who progressed after, or were intolerant to second- or later-generation TKI therapy and were intolerant or refractory to imatinib.1,2

BLINCYTO® single-agent immunotherapy

  • Continuous IV infusion for 2 induction cycles followed by up to 3 consolidation cycles2
  • Treatment cycle: 4 weeks on drug, 2 weeks off2
  • Dosing: 9 mcg/day on days 1–7 and 28 mcg/day on days 8–28 for cycle 1, and 28 mcg/day on days 1–28 for subsequent cycles2
 
 

Primary endpoint:2

  • CR/CRh* during first two cycles of treatment

Selected secondary endpoints:2

  • MRD response rate during the first two cycles of treatment
  • RFS
  • OS
  • HSCT after BLINCYTO®-induced remission
Key inclusion criteria2
Patients ≥ 18 years of age
Relapsed after or refractory to at least 1 second- or later-generation TKI or intolerant to second- or later-generation TKI and intolerant or refractory to imatinib
> 5% BM blasts
ECOG performance status ≤ 2
Key exclusion criteria2
HSCT within 12 weeks
Active acute or chronic Grade 2 to 4 GvHD
Systemic treatment of GvHD within 2 weeks before treatment start
History or presence of clinically relevant CNS pathology
Active CNS ALL
Isolated extramedullary disease

Difficult-to-treat patient population

  • BLINCYTO® was evaluated in difficult-to-treat patients, including those with prior ponatinib exposure, T315I mutation, and prior HSCT2

Baseline demographic and disease characteristics (N=45)1,2

Sex, n (%)
Male 24 (53)
Age group, n (%)
18 to < 55 years 22 (49)
55 to < 65 years 11 (24)
≥ 65 years 12 (27)
Prior TKI exposure, n (%)†
Dasatinib 39 (87)
Imatinib‡ 25 (56)
Ponatinib 23 (51)
Nilotinib 16 (36)
T315I mutation, n (%) 10 (27)§
Prior HSCT, n (%) 20 (44)
≥ 2 prior TKI treatments, n (%) 38 (84)
≥ 3 prior TKI treatments, n (%) 17 (38)

†Prior TKI use was not mutually exclusive.2

‡One patient was resistant to imatinib and was never exposed to a second-generation or later TKI (protocol deviation).2

§Of 37 patients evaluable for TKI mutational analysis.2

AYA, adolescent and young adult; CNS, central nervous system; ECOG, Eastern Cooperative Oncology Group; GvHD, graft versus host disease; IV, intravenous.

Blinatumomab is recommended by the National Comprehensive Cancer Network® (NCCN®) as a treatment option for both AYA and adult patients with R/R Ph(+) B-cell precursor ALL5

NCCN Recommended

The most common treatment-emergent adverse events (TEAEs) were pyrexia, febrile neutropenia, and headache2

Adverse events (regardless of causality)2


 Grade*

Any 1 to 2 3 4
Event No. % No. % No. % No. %
Patients with AEs 45 100 45 100 33 73 16 36
AEs of Grade ≥ 3 occurring in ≥ 5% of patients*
Pyrexia 26 58 24 53 5 11 0 0
Febrile neutropenia 18 40 9 20 12 27 0 0
Headache 14 31 13 29 3 7 0 0
Anemia 13 29 9 20 7 16 1 2
Thrombocytopenia 10 22 4 9 5 11 7 16
Pain 7 16 4 9 4 9 0 0
Increased aspartate aminotransferase 6 13 3 7 3 7 2 4
Increased alanine aminotransferase 5 11 1 2 5 11 0 0
Device-related infection 5 11 3 7 3 7 0 0
Neutropenia 3 7 0 0 0 0 3 7
  • No incidents of Grade ≥ 3 CRS were reported2
  • One patient died from septic shock, which was considered treatment-related by the investigator2

*Grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.2

Neurologic events were generally mild to moderate and were managed with dosage adjustments and/or treatment interruption2

Neurologic events (regardless of causality)2


 Grade†

Any 1 to 2 3 4
Event No. % No. % No. % No. %
Patients with neurologic events 21 47 20 44 3 7 0 0
Neurologic events occurring in two or more patients
Paresthesia 6 13 6 13 0 0 0 0
Confusional state 5 11 5 11 0 0 0 0
Dizziness 4 9 4 9 0 0 0 0
Tremor 4 9 4 9 0 0 0 0
Aphasia 2 4 1 2 1 2 0 0
Cerebellar syndrome 2 4 2 4 0 0 0 0
Memory impairment 2 4 2 4 0 0 0 0
Nervous system disorder 2 4 1 2 1 2 0 0
  • Neurologic events were reported in 21 (47%) patients; these were mild or moderate in all but 3 patients2
  • Three patients experienced a Grade 3 neurologic event (aphasia, hemiplegia, and nervous system disorder or depressed level of consciousness)2
  • One patient required treatment interruption due to neurologic events (aphasia)2

†Grading based on NCI CTCAE version 4.0.2

AE, adverse event; CRS, cytokine release syndrome.

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IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

  • Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO®. Interrupt or discontinue BLINCYTO® and treat with corticosteroids as recommended.
  • Neurological toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS), which may be severe, life-threatening or fatal, occurred in patients receiving BLINCYTO®. Interrupt or discontinue BLINCYTO® as recommended.
Contraindications

BLINCYTO® is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation.

Warnings and Precautions
  • Cytokine Release Syndrome (CRS): CRS, which may be life-threatening or fatal, occurred in patients receiving BLINCYTO®. The median time to onset of CRS is 2 days after the start of infusion and the median time to resolution of CRS was 5 days among cases that resolved. Closely monitor and advise patients to contact their healthcare professional for signs and symptoms of serious adverse events such as fever, headache, nausea, asthenia, hypotension, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased total bilirubin, and disseminated intravascular coagulation (DIC). The manifestations of CRS after treatment with BLINCYTO® overlap with those of infusion reactions, capillary leak syndrome (CLS), and hemophagocytic histiocytosis/macrophage activation syndrome (MAS). Using all of these terms to define CRS in clinical trials of BLINCYTO®, CRS was reported in 15% of patients with R/R ALL, in 7% of patients with MRD-positive ALL, and in 16% of patients receiving BLINCYTO® cycles in the consolidation phase of therapy. If severe CRS occurs, interrupt BLINCYTO® until CRS resolves. Discontinue BLINCYTO® permanently if life-threatening CRS occurs. Administer corticosteroids for severe or life-threatening CRS.
  • Neurological Toxicities, including Immune Effector Cell-Associated Neurotoxicity Syndrome:
    BLINCYTO® can cause serious or life-threatening neurologic toxicity, including ICANS. The incidence of neurologic toxicities in clinical trials was approximately 65%. The median time to the first event was within the first 2 weeks of BLINCYTO® treatment. The most common (≥ 10%) manifestations of neurological toxicity were headache and tremor. Grade 3 or higher neurological toxicities occurred in approximately 13% of patients, including encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders. Manifestations of neurological toxicity included cranial nerve disorders. The majority of neurologic toxicities resolved following interruption of BLINCYTO®, but some resulted in treatment discontinuation.

    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.

  • Infections: Approximately 25% of patients receiving BLINCYTO® in clinical trials experienced serious infections such as sepsis, pneumonia, bacteremia, opportunistic infections, and catheter-site infections, some of which were life-threatening or fatal. Administer prophylactic antibiotics and employ surveillance testing as appropriate during treatment. Monitor patients for signs or symptoms of infection and treat appropriately, including interruption or discontinuation of BLINCYTO® as needed.
  • Tumor Lysis Syndrome (TLS), which may be life-threatening or fatal, has been observed. Preventive measures, including pretreatment nontoxic cytoreduction and on-treatment hydration, should be used during BLINCYTO® treatment. Monitor patients for signs and symptoms of TLS and interrupt or discontinue BLINCYTO® as needed to manage these events.
  • Neutropenia and Febrile Neutropenia, including life-threatening cases, have been observed. Monitor appropriate laboratory parameters (including, but not limited to, white blood cell count and absolute neutrophil count) during BLINCYTO® infusion and interrupt BLINCYTO® if prolonged neutropenia occurs.
  • Effects on Ability to Drive and Use Machines: Due to the possibility of neurological events, including seizures and ICANS, patients receiving BLINCYTO® are at risk for loss of consciousness, and should be advised against driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery while BLINCYTO® is being administered.
  • Elevated Liver Enzymes: Transient elevations in liver enzymes have been associated with BLINCYTO® treatment with a median time to onset of 3 days. In patients receiving BLINCYTO®, although the majority of these events were observed in the setting of CRS, some cases of elevated liver enzymes were observed outside the setting of CRS, with a median time to onset of 19 days. Grade 3 or greater elevations in liver enzymes occurred in approximately 7% of patients outside the setting of CRS and resulted in treatment discontinuation in less than 1% of patients. Monitor ALT, AST, gamma-glutamyl transferase, and total blood bilirubin prior to the start of and during BLINCYTO® treatment. BLINCYTO® treatment should be interrupted if transaminases rise to > 5 times the upper limit of normal (ULN) or if total bilirubin rises to > 3 times ULN.
  • Pancreatitis: Fatal pancreatitis has been reported in patients receiving BLINCYTO® in combination with dexamethasone in clinical trials and the post-marketing setting. Evaluate patients who develop signs and symptoms of pancreatitis and interrupt or discontinue BLINCYTO® and dexamethasone as needed.
  • Leukoencephalopathy: Although the clinical significance is unknown, cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy have been observed in patients receiving BLINCYTO®, especially in patients previously treated with cranial irradiation and antileukemic chemotherapy.
  • Preparation and administration errors have occurred with BLINCYTO® treatment. Follow instructions for preparation (including admixing) and administration in the PI strictly to minimize medication errors (including underdose and overdose).
  • Immunization: Vaccination with live virus vaccines is not recommended for at least 2 weeks prior to the start of BLINCYTO® treatment, during treatment, and until immune recovery following last cycle of BLINCYTO®.
  • Benzyl Alcohol Toxicity in Neonates: Serious adverse reactions, including fatal reactions and the “gasping syndrome,” have been reported in very low birth weight (VLBW) neonates born weighing less than 1500 g, and early preterm neonates (infants born less than 34 weeks gestational age) who received intravenous drugs containing benzyl alcohol as a preservative. Early preterm VLBW neonates may be more likely to develop these reactions, because they may be less able to metabolize 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 (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.

  • Embryo-Fetal Toxicity: Based on its mechanism of action, BLINCYTO® may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with BLINCYTO® and for 48 hours after the last dose.
Adverse Reactions
  • The safety of BLINCYTO® in adult and pediatric patients one month and older with MRD-positive B-cell precursor ALL (n=137), relapsed or refractory B-cell precursor ALL (n=267), and Philadelphia chromosome-negative B-cell precursor ALL in consolidation (n=165) was evaluated in clinical studies. The most common adverse reactions (≥ 20%) to BLINCYTO® in this pooled population were pyrexia, infusion-related reactions, headache, infection, musculoskeletal pain, neutropenia, nausea, anemia, thrombocytopenia, and diarrhea.
Dosage and Administration Guidelines
  • BLINCYTO® is administered as a continuous intravenous infusion at a constant flow rate using an infusion pump which should be programmable, lockable, non-elastomeric, and have an alarm.
  • It is very important that the instructions for preparation (including admixing) and administration provided in the full Prescribing Information are strictly followed to minimize medication errors (including underdose and overdose).
INDICATIONS

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
  • Minimal residual disease (MRD) greater than or equal to 0.1% in first or second complete remission
  • Relapsed or refractory disease

Please see BLINCYTO® full Prescribing Information, including BOXED WARNINGS.

BLINCYTO® is a registered trademark of Amgen Inc.

See more

IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

  • Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO®. Interrupt or discontinue BLINCYTO® and treat with corticosteroids as recommended.
  • Neurological toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS), which may be severe, life-threatening or fatal, occurred in patients receiving BLINCYTO®. Interrupt or discontinue BLINCYTO® as recommended.
Contraindications
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References: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen. 2. Martinelli G, Boissel N, Chevallier P, et al. Complete hematologic and molecular response in adult patients with relapsed/refractory Philadelphia chromosome–positive B-precursor acute lymphoblastic leukemia following treatment with blinatumomab: results from a phase II, single-arm, multicenter study. J Clin Oncol. 2017;35:1795-1802. 3. Data on file, Amgen; 2014. 4. ClinicalTrials.gov. Blinatumomab in adults with relapsed/refractory Philadelphia positive B-precursor acute lymphoblastic leukemia. https://clinicaltrials.gov/ct2/show/NCT02000427. Accessed April 2, 2025. 5. 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.