Asset 1
Indications

BLINCYTO® (blinatumomab) is indicated for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adult and pediatric patients. ... Read More 

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

Important Safety Information Prescribing Information Medication Guide Indications Patient Site 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

The importance of MRD

Unmet need in ALL

Acute lymphoblastic leukemia (ALL) is a rare but often fatal disease that may occur at any age1,2

In the US, an estimated 6,540 new cases and 1,390 deaths due to acute lymphoblastic leukemia (ALL) will occur in 2023, with 53.5% of these new cases occurring among those aged < 20 years.1 Additionally, ALL is associated with reduced survival with increasing age.2

5-year relative survival in patients with ALL by age group, US, 2013–20192,*

Five-year relative survival in patients with ALL by age group, US 2013-2019

*Results from SEER 22 in patients with ALL from 2013–2019.2

ALL is associated with a risk of relapse3,4

Adult and pediatric patients with acute lymphoblastic leukemia (ALL) who achieve complete remission (CR) may still have residual leukemic cells in the bone marrow, which is associated with a risk of relapse.5,6

40% - 50% adult patients, 15% - 20% of pediatric patients
40% - 50% adult patients, 15% - 20% of pediatric patients

with ALL who achieve CR after chemotherapy may relapse3,4

Importance of MRD

What is MRD?

In ALL, measurable residual disease or minimal residual disease (MRD) is defined as the presence of detectable leukemic cells within the bone marrow or peripheral blood during morphologic CR, typically defined as < 5% bone marrow blasts.7 While there is no consensus on a precise definition of MRD positivity, a sensitivity threshold of 10-4 has been shown to predict patient outcomes.7

About 40% of adult patients with acute lymphoblastic leukemia may test positive of MRD
About 40% of adult patients with acute lymphoblastic leukemia may test positive of MRD

MRD positivity may be indicative of treatment response in patients with ALL.9,10

MRD is a strong prognostic indicator for relapse in ALL11

The presence of MRD following induction therapy is associated with a high risk of relapse, and subsequent MRD monitoring may be useful for identifying residual disease before overt relapse occurs.5 Furthermore, MRD positivity at the time of HSCT is associated with an increased risk of relapse post-HSCT.5 Due to this risk, the NCCN Guidelines for ALL recommend "eliminating MRD prior to allogeneic HCT," when possible.12

Patterns of response and relapse in ALL11

MRD Testing

NCCN Guidelines for ALL recommend MRD testing throughout the patient journey12,13

MRD assessment is considered an essential component of patient evaluation over the course of sequential therapy in adult and pediatric patients with ALL12,13,*

NCCN Guidelines state that the optimal sample for MRD assessment is the first small volume (of up to 3 mL) pull of the bone marrow aspirate.12,14 In fact, the second pull has been shown to have a nearly 50% average reduction in leukemic cells. Additionally, a small sample volume is preferred, as it may contain a higher proportion of blasts than large sample volumes (eg, 10 mL).14

Facilities conducting MRD testing download
Facilities conducting MRD testing
See all CLIA-certified external testing facilities for MRD in ALL
Download

*AYA patients can be included in either pediatric or adult patient populations.12,13

†Dependent on MRD testing technique used.12,13

‡Additional time points should be guided by the regimen used. Serial monitoring frequency may be increased in patients with molecular relapse or persistent low-level disease burden.12,13

§MRD testing may be included with a bone marrow aspirate.12,13

AYA, adolescent and young adult; HCT, hematopoietic cell transplantation; HSCT, allogeneic hematopoietic stem cell transplantation; NCCN, National Comprehensive Cancer Network; SEER, Surveillance, Epidemiology, and End Results.

MRD is a strong prognostic indicator for relapse in acute lymphoblastic leukemia (ALL)11

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

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, 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. Monitor patients for signs or symptoms of neurological toxicities, including ICANS, 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 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 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®.
  • 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® 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 most common adverse reactions (≥ 20%) are pyrexia, infusion-related reactions, infections (pathogen unspecified), headache, neutropenia,
    anemia, and thrombocytopenia.
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 first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adult and pediatric patients.
  • BLINCYTO® is indicated for the treatment of relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients.

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

References: 1. National Cancer Institute. https://seer.cancer.gov/statfacts/html/alyl.html. Accessed June 08, 2023. 2. National Cancer Institute. https://seer.cancer.gov/statistics-network/explorer/application.html?site=92&data_type=4&graph_type=5&compareBy=age_range&chk_age_range_16=16&chk_age_range_62=62&chk_age_range_122=122&chk_age_range_160=160&chk_age_range_166=166&series=9&sex=1&race=1&hdn_stage=101&advopt_precision=1&advopt_show_ci=on&hdn_view=0&advopt_show_apc=on&advopt_display=2#resultsRegion0. Accessed June 05, 2023. 3. Hoelzer D. Monitoring and managing minimal residual disease in acute lymphoblastic leukemia. Am Soc Clin Oncol Educ Book. 2013;33:290-293. 4. Cooper SL, Brown PA. Treatment of pediatric acute lymphoblastic leukemia. Pediatr Clin North Am. 2015;62:61-73. 5. Campana D. Minimal residual disease in acute lymphoblastic leukemia. Semin Hematol. 2009;46:100-106. 6. Paganin M, Zecca M, Fabbri G, et al. Minimal residual disease is an important predictive factor of outcome in children with relapsed ‘high-risk’ acute lymphoblastic leukemia. Leukemia. 2008;22:2193-2200. 7. Akabane H, Logan AC. Clinical significance and management of MRD in adults with acute lymphoblastic leukemia. Clin Adv Hematol Oncol. 2020;18:413-422. 8. Brüggemann M, Raff T, Flohr T, et al. Clinical significance of minimal residual disease quantification in adult patients with standard-risk acute lymphoblastic leukemia. Blood. 2006;107:1116-1123. 9. Kotrova M, Trka J, Kneba M, et al. Is next-generation sequencing the way to go for residual disease monitoring in acute lymphoblastic leukemia? Mol Diagn Ther. 2017;21:481-492. 10. Chen X, Wood BL. How do we measure MRD in ALL and how should measurements affect decisions. Re: Treatment and prognosis? Best Pract Res Clin Haematol. 2017;30:237-248. 11. Short NJ, Jabbour E, Albitar M, et al. Recommendations for the assessment and management of measurable residual disease in adults with acute lymphoblastic leukemia: A consensus of North American experts. Am J Hematol. 2019;94:257-265. 12. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia v.1.2023. ©National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed June 2, 2023. 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. 13. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Pediatric Acute Lymphoblastic Leukemia v.2.2023. ©National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed March 13, 2023. 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. 14. Helgestad J, Rosthøj S, Johansen P, et al. Bone marrow aspiration technique may have an impact on therapy stratification in children with acute lymphoblastic leukaemia. Pediatr Blood Cancer. 2011;57:224-226.

BACK TO TOP