Indication

BLINCYTO® is indicated for the treatment of relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children.

Asset 1
Important Safety Information Prescribing Information Medication Guide Indication BLINCYTO® REMS Patient Site Other Indication Connect with a BLINCYTO® rep

Connect with a BLINCYTO® (blinatumomab) representative

Do you have questions about BLINCYTO® treatment? Enter your information today and a representative will be in touch with you soon.

First Name

Enter first name

Last Name

Enter last name

Email

Enter email address

Phone Number

Enter Phone Number

Address

Address

City

Enter City

State

State

Zip Code

Enter Zip Code

Select your title

Please check the box to continue.

Privacy Statement By clicking "Submit," you agree to disclose your personal information to Amgen and to be contacted by Amgen and their agents in the future regarding products, services, and/or information related to BLINCYTO®. For more information about Amgen's privacy practices, please visit www.amgen.com/privacy.

Submit

Thank you! A BLINCYTO® (blinatumomab) representative will be in touch with you soon.

Close

BLINCYTO® has a growing body of evidence as a treatment for pediatric and AYA patients in first relapse of CD19-positive B-cell precursor ALL1-3

MT103-205 study MT103-205 study

MT103-205, the pivotal study of BLINCYTO® in pediatric patients3

  • MT103-205 study design: an international, open-label, single-arm, phase 1/2 study3

BLINCYTO® was studied as a single-agent therapy via continuous IV infusion4

  • Phase 1: Dose finding
  • Phase 2:
    • Dosage: 5/15 mcg/m2/day (5 mcg/m2/day for the first week of the first cycle followed by 15 mcg/m2/day thereafter)
    • Treatment cycle: 4 weeks on treatment, 2 weeks off
Key inclusion criteria4
Primary refractory disease
First relapse after full salvage induction
Second or later relapse, or in any relapse after HSCT
Age < 18 years
KPS ≥ 50% or LPS ≥ 50% for patients < 16 years of age
Key exclusion criteria4
Active acute or extensive chronic GvHD after HSCT
Evidence of active CNS involvement
Evidence of active testicular involvement
MT103-205 included heavily pretreated pediatric patients4

Baseline Characteristics (N=70)4,‡

Sex, n (%)
Male 47 (67)
Age, n (%)
< 2 years 10 (14)
2–6 years 20 (29)
7–17 years 40 (57)
Previous relapses, n (%)
0 (primary refractory disease) 2 (3)
1 31 (44)
2 29 (41)
≥ 3 8 (11)
Previous HSCT, n (%) 40 (57)
Baseline BM blasts, n (%)
< 50% 18 (26)
≥ 50% 52 (74)
74%
of patients had high tumor burden

‡All patients treated at the stepwise dosage of 5 or 15 mcg/m2/day in phase 1 or phase 2.4

CNS, central nervous system; GvHD, graft versus host disease; IV, intravenous; KPS, Karnofsky performance status; LPS, Lansky performance status.

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend blinatumomab (BLINCYTO®) as a treatment option for pediatric patients with B-cell precursor ALL in first relapse5

About a third of all patients achieved CR/CRh* within the first 2 cycles of BLINCYTO®3

Primary endpoint was CR/CRh* in the first 2 cycles3,†

Within the First Two Treatment Cycles of BLINCYTO®

Treatment Cycles Treatment Cycles
  • 73.9% of CR/CRh* occurred in cycle 1 (n=17/23)3
  • 26.1% of CR/CRh* occurred in cycle 2 (n=6/23)3

†CR was defined as ≤ 5% of blasts in the BM, no evidence of circulating blasts or extramedullary disease, and full recovery of peripheral blood counts (platelets > 100,000/microliter and ANC > 1,000/microliter). CRh* was defined as ≤ 5% of blasts in the BM, no evidence of circulating blasts or extramedullary disease, and partial recovery of peripheral blood counts (platelets > 50,000/microliter and ANC > 500/microliter).3

ALL, acute lymphoblastic leukemia; ANC, absolute neutrophil count; AYA, adolescent and young adult; BM, bone marrow; CD, cluster of differentiation; CI, confidence interval; CR, complete remission; CRh*, complete remission with partial hematologic recovery; HSCT, allogeneic hematopoietic stem cell transplantation; NCCN, National Comprehensive Cancer Network.

Amgen 20120215 study Amgen 20120215 study

Amgen 20120215 study design and baseline characteristics of patients

Patients > 28 days and < 18 years of age with Ph(–) B-cell precursor ALL in high-risk first relapse1,§

Reinduction chemotherapy followed by 2 blocks of high-risk consolidation chemotherapy**
1:1
Randomization
1
1
BLINCYTO® consolidation (n=54)
•One cycle of BLINCYTO® (15 mcg/m2/day for 28 days)
Chemotherapy consolidation (n=54)
•Third block of high-risk consolidation chemotherapy††
HSCT
Reinduction chemotherapy followed by 2 blocks of high-risk consolidation chemotherapy**
1:1
Randomization
1
1
BLINCYTO®
consolidation (n=54)
•One cycle of BLINCYTO® (15 mcg/m2/day for 28 days)
Chemotherapy consolidation (n=54)
•Third block of high-risk consolidation chemotherapy††
HSCT

Primary endpoint:1

  • Event-free survival

Selected secondary endpoints:1

  • Overall survival
  • Incidence of relapse
  • MRD response
  • Incidence of AEs
Key inclusion criteria1
High-risk B-cell precursor ALL in first relapse
< 5% blasts or between 5%–25% blasts in BM
Key exclusion criteria1
Clinically relevant CNS pathology requiring treatment
Evidence of current CNS (CNS2, CNS3) involvement by ALL§§
Abnormal renal or hepatic function prior to start of treatment
Enrollment was closed early based on the statistically significant difference in efficacy of BLINCYTO® vs chemotherapy at a predefined efficacy threshold of 50% EFS events interim analysis1

§§CNS2, patients with WBC count in CSF < 5 per microliter and having blasts in the CSF; CNS3, patients with WBC count in CSF ≥ 5 per microliter and having blasts in the CSF.2

CSF, cerebrospinal fluid; WBC, white blood cell.

Demographic and clinical characteristics of children at randomization in the trial of BLINCYTO® vs chemotherapy in high-risk first relapse1

BLINCYTO ®
(n=54)
n (%) 		Chemotherapy
(n=54)
n (%)
Age at enrollment (years)
Median (range) 		6 (1–17) 5 (1–17)
1–9 39 (72.2) 38 (70.4)
10–18 15 (27.8) 16 (29.6)
Sex
Female 24 (44.4) 32 (59.3)
Male 30 (55.6) 22 (40.7)
Genetic abnormalities at diagnosis of first high-risk relapse
Favorable prognosis
Hyperdiploidy
t(12;21) (p13;q22)/TEL-AML1 		8 (14.8)
6 (11.1)
2 (3.7) 		10 (18.5)
6 (11.1)
4 (7.4)
Unfavorable prognosisa
t(v;11q23)/KMT2A rearranged
t(1;19)(q23;p13.3)/E2A-PBX1
Hyperdiploidy 		7 (13.0)
2 (3.7)
2 (3.7)
2 (3.7)
9 (16.7)
6 (11.1)
2 (3.7)
0 (0.0)
Prognosis undefined 5 (9.3) 6 (11.1)
13%
of patients in the BLINCYTO® arm and 16.7% of patients in
the chemotherapy arm had an unfavorable prognosis

aOne patient in the blinatumomab group with IAMP21 and one patient in the consolidation chemotherapy group with t(17;19)(q22;p13)/TCF3-HLF also carried a genetic abnormality predicting an unfavorable prognosis.1

BLINCYTO® demonstrated superior EFS and improved OS vs chemotherapy in pediatric patients with B-cell precursor ALL in high-risk first relapse1

EFS for BLINCYTO® vs chemotherapy1

EFS vs chemotherapy

EFS vs chemotherapy

Patients who did not achieve remission or died before assessment were assigned one day of event-free survival. Patients alive and event free were censored on their last assessment date.

  • At the median follow-up of 22.4 months, EFS was 69% for BLINCYTO® and 43% for chemotherapy1

2-year OS for BLINCYTO® vs chemotherapy1

  • At the median follow-up of 19.5 months, the HR for OS was 0.43 (95% CI: 0.18–1.01)1

AE, adverse event; EFS, event-free survival; EM, extramedullary; HC1, high-risk consolidation block 1; HC2, high-risk consolidation block 2; HC3, high-risk consolidation block 3; HR, hazard ratio; iBM, isolated bone marrow; iEM, isolated extramedullary; IM, intramuscular; MRD, measurable or minimal residual disease; OS, overall survival; Ph(–), Philadelphia chromosome-negative.

BLINCYTO® converted most patients to MRD(–)‡‡ and more patients proceeded to HSCT vs chemotherapy1

MRD
response rate

90%

(n=44/49)

of patients who received BLINCYTO® achieved MRD(–)‡‡ vs 54% (n=26/48) of patients who received chemotherapy1

More patients who received BLINCYTO® proceeded to HSCT while in remission1

HSCT

HSCT

  • Number of patients who proceeded to HSCT while in remission was part of a post hoc analysis. Analysis is exploratory and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn

‡‡MRD < 10–4, evaluated in a central laboratory by PCR.1

PCR, polymerase chain reaction.

See the full safety profile of the Amgen 20120215 study

Learn more

§§MRD < 10 –4, evaluated in a central laboratory by PCR.1

OS, overall survival; PCR, polymerase chain reaction.

COG AALL 1331 study COG AALL 1331 study

COG AALL1331 study design and baseline characteristics of patients

Patients 1–27 years of age with Ph(–) B-cell precursor ALL in high-risk or intermediate-risk first relapse2

BLINCYTO® (blinatumomab) consolidation

BLINCYTO® (blinatumomab) consolidation

Primary endpoint:2

Disease-free survival

Secondary endpoint:2

Overall survival

Exploratory endpoint:2

MRD response

Exploratory endpoint:2

MRD response

Secondary endpoint:2

Overall survival

Post hoc endpoint:2

Ability to proceed to HSCT

Key inclusion criteria2
B-cell precursor ALL in first relapse
Key exclusion criteria2
Down syndrome
Ph(+) B-cell precursor ALL
Previous HSCT or BLINCYTO® treatment
Enrollment was terminated early in the HR and IR groups due to encouraging efficacy and lower rates of serious toxicity in the BLINCYTO® arm vs chemotherapy, based on a recommendation from the Independent Data Safety Monitoring Committee2

BLINCYTO® was evaluated in high-risk and intermediate-risk pediatric and AYA patients in first relapse2

Baseline characteristics2

BLINCYTO ®
(n=105)
n (%) 		Chemotherapy
(n=103)
n (%)
Age at enrollment (years)
Median (interquartile range) 		9 (6–16) 9 (5–16)
1–9 55 (52.4) 55 (53.4)
10–12 10 (9.5) 11 (10.7)
13–17 25 (23.8) 19 (18.4)
18–20 8 (7.6) 10 (9.7)
21–27 7 (6.7) 8 (7.8)
Sex
Female 48 (45.7) 49 (47.6)
Male 57 (54.3) 54 (52.4)
Risk group assignment after reinduction
High risk*** 69 (65.7) 69 (67.0)
Intermediate risk††† 36 (34.3) 34 (33.0)
Cytogenetic group at diagnosis
Favorable
ETV6-RUNX1, No.
Hyperdiploid with +4, +10, No. 		21 (23.3)
12
9 		16 (17.6)
8
8
Unfavorable
KMT2A-rearranged, No.
Hyperdiploid, No. 		7 (7.8)
7
0 		10 (11.0)
9
1
Other
Unknown, No. 		62 (68.9)
15		 65 (71.4)
12
~ 66%
of patients were high-risk

HR, high risk; IR, intermediate risk; Ph(+), Philadelphia chromosome–positive.

BLINCYTO® demonstrated improved DFS and OS vs chemotherapy for high-risk and intermediate-risk pediatric and AYA patients2,***,†††

2-year DFS for BLINCYTO® vs chemotherapy2

OS for BLINCYTO® vs chemotherapy2

Amgen 20120215 study design

Amgen 20120215 study design

  • Median follow-up was 2.9 years2

COG, Children's Oncology Group; DFS, disease-free survival; HSCT, hematopoietic stem cell transplantation; IT, intrathecal.

More patients achieved an MRD response and proceeded to HSCT with BLINCYTO® vs chemotherapy2

MRD response after cycle 1 of BLINCYTO® vs block 2 of chemotherapy2,††††

MRD
response rate‡‡‡‡

75%

(n=79/105)

of patients who received BLINCYTO® achieved MRD(–) vs 32% (n=33/103) of patients who received chemotherapy§§§§

  • MRD response was an exploratory endpoint. Analysis is exploratory and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn2

More patients who received BLINCYTO® proceeded to HSCT vs those who received chemotherapy2

HSCT

HSCT

  • Number of patients who proceeded to HSCT while in remission was part of a post hoc analysis. Analysis is exploratory and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn2

††††All patients received one block of chemotherapy prior to randomization. Data reflect MRD response for patients who received the first cycle of BLINCYTO® in the BLINCYTO® treatment arm vs patients who received the second block of chemotherapy in the chemotherapy treatment arm.2

‡‡‡‡MRD < 0.01%, evaluated in a central laboratory by flow cytometry.2

§§§§In this analysis, positive MRD or no MRD data are considered as not having negative MRD. The rationale for including patients with no MRD data is that the lack of MRD data was due to death, relapse, or removal from protocol therapy because of an AE or other poor response to therapy, so it is appropriate to include them as the converse of the optimal outcome of being able to submit a sample and have negative MRD.2

See the safety results of BLINCYTO® vs chemotherapy in COG AALL1331

Learn more

References: 1. Locatelli F, Zugmaier G, Rizzari C, et al. Effect of blinatumomab vs chemotherapy on event-free survival among children with high-risk first-relapse B-cell acute lymphoblastic leukemia: a randomized clinical trial. JAMA. 2021;325:843-854. 2. Brown PA, Ji L, Xu X, et al. Effect of postreinduction therapy consolidation with blinatumomab vs chemotherapy on disease-free survival in children, adolescents, and young adults with first relapse of B-cell acute lymphoblastic leukemia: a randomized clinical trial. JAMA. 2021;325:833-842. 3. BLINCYTO® (blinatumomab) prescribing information, Amgen. 4. von Stackelberg A, Locatelli F, Zugmaier G, et al. Phase I/phase II study of blinatumomab in pediatric patients with relapsed/refractory acute lymphoblastic leukemia. J Clin Oncol. 2016;34:4381-4389. 5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN guidelines®) for Pediatric Acute Lymphoblastic Leukemia V.1.2022. ©National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed June 28, 2022. 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. 6. Data on file, Amgen; 2020. 7. Parker C, Waters R, Leighton C, et al. Effect of mitoxantrone on outcome of children with first relapse of acute lymphoblastic leukaemia (ALL R3): an open-label randomised trial. Lancet. 2010;376:2009-2017.

See more

IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES

  • 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, 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 15% of patients with R/R ALL and in 7% of patients with MRD-positive ALL. 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 (TBILI), and disseminated intravascular coagulation (DIC). The manifestations of CRS after treatment with BLINCYTO® overlap with those of infusion reactions, capillary leak syndrome, and hemophagocytic histiocytosis/macrophage activation syndrome. 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: Approximately 65% of patients receiving BLINCYTO® in clinical trials experienced neurological toxicities. The median time to the first event was within the first 2 weeks of BLINCYTO® treatment and the majority of events resolved. The most common (≥ 10%) manifestations of neurological toxicity were headache and tremor. Severe, life‐threatening, or fatal 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. Monitor patients for signs or symptoms and interrupt or discontinue BLINCYTO® as outlined in the PI.
  • 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, 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 TBILI 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 TBILI 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®.
  • Risk of Serious Adverse Reactions in Pediatric Patients due to Benzyl Alcohol Preservative: Serious and fatal adverse reactions including “gasping syndrome,” which is characterized by central nervous system depression, metabolic acidosis, and gasping respirations, can occur in neonates and infants treated with benzyl alcohol-preserved drugs including BLINCYTO® (with preservative). When prescribing BLINCYTO® (with preservative) for pediatric patients, consider the combined daily metabolic load of benzyl alcohol from all sources including BLINCYTO® (with preservative) and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. Due to the addition of bacteriostatic saline, 7-day bags of BLINCYTO® solution for infusion with preservative contain benzyl alcohol and are not recommended for use in any patients weighing < 22 kg.
Adverse Reactions
  • The most common adverse reactions (≥ 20%) in clinical trial experience of patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL (TOWER Study) treated with BLINCYTO® were infections (bacterial and pathogen unspecified), pyrexia, headache, infusion-related reactions, anemia, febrile neutropenia, thrombocytopenia, and neutropenia. Serious adverse reactions were reported in 62% of patients. The most common serious adverse reactions (≥ 2%) included febrile neutropenia, pyrexia, sepsis, pneumonia, overdose, septic shock, CRS, bacterial sepsis, device related infection, and bacteremia.
  • Adverse reactions that were observed more frequently (≥ 10%) in the pediatric population compared to the adults with relapsed or refractory B-cell precursor ALL were pyrexia (80% vs. 61%), hypertension (26% vs. 8%), anemia (41% vs. 24%), infusion-related reaction (49% vs. 34%), thrombocytopenia (34% vs. 21%), leukopenia (24% vs. 11%), and weight increased (17% vs. 6%).
  • In pediatric patients less than 2 years old (infants), the incidence of neurologic toxicities was not significantly different than for the other age groups, but its manifestations were different; the only event terms reported were agitation, headache, insomnia, somnolence, and irritability. Infants also had an increased incidence of hypokalemia (50%) compared to other pediatric age cohorts (15-20%) or adults (17%).
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).
INDICATION
  • BLINCYTO® is indicated for the treatment of relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, for BLINCYTO®.

BLINCYTO® is a registered trademark of Amgen Inc.

See more

IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES

  • 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, which may be severe, life-threatening or fatal, occurred in patients receiving BLINCYTO®. Interrupt or discontinue BLINCYTO® as recommended.
BACK TO TOP