Asset 1
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

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

You are now leaving BLINCYTOHCP.com

The content of the linked site is the sole responsibility of the site provider. Amgen Inc. does not control or endorse this third-party website.

Go back to Blincytohcp.com
External Page

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

BLINCYTO® data in frontline consolidation

E1910 study design: 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.2,3 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.2

Overall population aged 30-70 years†
5-year KM estimates for OS2

82.4%

BLINCYTO® arm
(n=112)

vs

62.5%

Chemotherapy only
arm (n=112)

HR: 0.44 (95% CI: 0.25–0.76)

Subgroup of patients aged 30–39 years
3-year OS4

100%

BLINCYTO® arm
(n=21)

vs

73%

Chemotherapy only
arm (n=26)

Efficacy in this subgroup was not a prespecified study objective and the study was not powered to assess efficacy in this subgroup.3

See safety data for E1910 

*The hazard ratio estimates are obtained from a stratified Cox regression model at the third interim analysis.2

†In a later analysis with a median follow-up of 4.5 years.2

Camila’s frontline consolidation journey

Every patient's journey is unique

Deemed a good candidate for transplant but is advised not to proceed at CR1 as MRD-negative status was achieved

Receives frontline consolidation with cycles 1 and 2 of BLINCYTO®, with hospitalization at academic medical center for the first 3 days of the first cycle and first 2 days of the second cycle, and transitions to the hospital-owned outpatient infusion center thereafter2

Receives additional frontline consolidation treatment with a multiagent BFM-like regimen (CALGB 10403), alternating with cycles 3 and 4 of blinatumomab (BLINCYTO®) at the hospital-owned outpatient infusion center1,2

Don't wait, integrate BLINCYTO® into frontline consolidation across all ages‡ regardless of chemotherapy and MRD status

‡Indicated in adult and pediatric patients 1 month and older.2

ALL, acute lymphoblastic leukemia; AYA, adolescent and young adult; BFM, Berlin-Frankfurt-Münster; CD, cluster of differentiation; CI, confidence interval; CR1, first complete remission; HR, hazard ratio; KM, Kaplan-Meier; MRD, measurable or minimal residual disease; OS, overall survival; Ph(–), Philadelphia chromosome–negative.

References: 1. 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. 2. BLINCYTO® (blinatumomab) prescribing information, Amgen. 3. 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. 4. Dinner S, Sun Z, Paietta E, et al. Addition of blinatumomab to consolidation therapy for younger adults (< 55 years) with newly diagnosed BCR:ABL1-negative B-acute lymphoblastic leukemia (ALL) on the ECOG-ACRIN E1910 phase III trial. Presented at: 30th EHA Congress; June 12–15, 2025; Milan, Italy.

BLINCYTO® data in frontline consolidation

E1910 study design: 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.2,3 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.2

Overall population aged 30-70 years†
5-year KM estimates for OS2

82.4%

BLINCYTO® arm
(n=112)

vs

62.5%

Chemotherapy only
arm (n=112)

HR: 0.44 (95% CI: 0.25–0.76)

Subgroup of patients aged < 55 years
3-year OS4

92%

BLINCYTO® arm
(n=66)

vs

67%

Chemotherapy only
arm (n=66)

HR: 0.20 (95% CI: 0.08–0.54)

See safety data for E1910 

*The hazard ratio estimates are obtained from a stratified Cox regression model at the third interim analysis.2

†In a later analysis with a median follow-up of 4.5 years.2

Winona’s frontline consolidation journey

Every patient's journey is unique

Deemed a good candidate for transplant but a suitable donor was not found

Receives frontline consolidation with cycles 1 and 2 of BLINCYTO® with hospitalization at a large community hospital (requiring travel) for the first 3 days of the first cycle and the first 2 days of the second cycle, and transition to a community oncology clinic closer to home thereafter2

Receives additional frontline consolidation treatment with a multiagent regimen (hyper-CVAD), alternating with cycles 3 and 4 of blinatumomab (BLINCYTO®) at the community oncology clinic1,2

Don't wait, integrate BLINCYTO® into frontline consolidation across all ages‡ regardless of chemotherapy and MRD status

‡Indicated in adult and pediatric patients 1 month and older.2

ALL, acute lymphoblastic leukemia; CD, cluster of differentiation; CI, confidence interval; HR, hazard ratio; hyper-CVAD, hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone; KM, Kaplan-Meier; MRD, measurable or minimal residual disease; OS, overall survival; Ph(–), Philadelphia chromosome–negative.

References: 1. 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. 2. BLINCYTO® (blinatumomab) prescribing information, Amgen. 3. 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. 4. Dinner S, Sun Z, Paietta E, et al. Addition of blinatumomab to consolidation therapy for younger adults (< 55 years) with newly diagnosed BCR:ABL1-negative B-acute lymphoblastic leukemia (ALL) on the ECOG-ACRIN E1910 phase III trial. Presented at: 30th EHA Congress; June 12–15, 2025; Milan, Italy.

BLINCYTO® data in the relapsed or refractory setting

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 Ph(+) R/R 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

CR/CRh* rate within the first 2 treatment cycles (primary endpoint)1

36%

BLINCYTO® arm
(n=45)

MRD response among those who achieved
CR/CRh* within the first 2 treatment cycles1,2

88%

BLINCYTO® arm
(n=16)

Kaya’s next steps in her treatment journey

Every patient's journey is unique

Receives 2 cycles of BLINCYTO® induction with hospitalization at the community hospital for the first 9 days of the first cycle and the first 2 days of the second cycle, and transitions to a community oncology clinic closer to home thereafter1

Achieves CR and MRD negativity after 2 cycles of BLINCYTO®

Receives 3 cycles of BLINCYTO® consolidation at community oncology clinic1

Undergoes evaluation for transplant eligibility and is deemed a good candidate

Proceeds to HSCT

Don't wait, integrate BLINCYTO® regardless of Philadelphia chromosome status

ALL, acute lymphoblastic leukemia; AYA, adolescent and young adult; CD, cluster of differentiation; CR, complete remission; CRh*, complete remission with partial hematologic recovery; HSCT, allogeneic hematopoietic stem cell transplantation; MRD, measurable or minimal residual disease; Ph(+), Philadelphia chromosome–positive; R/R, relapsed or refractory; TKI, tyrosine kinase inhibitor.

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.

BLINCYTO® data in the relapsed or refractory setting

TOWER study design: A large (N=405), international, randomized, controlled, phase 3 study of single-agent BLINCYTO® vs SOC chemotherapy in patients ≥ 18 years of age: refractory to primary induction therapy or to last therapy, in first relapse (first remission duration < 12 months), in second or later relapse, or in any relapse after HSCT.1,2

Median OS (primary endpoint)1,†

7.7 mo

BLINCYTO® arm
(n=271)

vs

4.0 mo

Chemotherapy only
arm (n=134)

HR: 0.71 (95% CI: 0.55–0.93); P = 0.012

CR/CRh*/CRi rates2,‡,§

44%

BLINCYTO® arm
(n=271)

vs

25%

Chemotherapy only
arm (n=134)

See safety data for TOWER

†Median follow-up was 11.7 and 11.8 months in the BLINCYTO® and chemotherapy arms, respectively.2

‡Within 12 weeks after treatment initiation.2

§CR was defined as ≤ 5% blasts in the BM, no evidence of disease, and full recovery of peripheral blood counts (platelets > 100,000/μL and ANC > 1,000/μL). CRh* was defined as ≤ 5% blasts in the BM, no evidence of disease, and partial recovery of peripheral blood counts (platelets > 50,000/μL and ANC > 500/μL). CRi was defined as ≤ 5% blasts in the BM, no evidence of disease, and incomplete recovery of peripheral blood counts (platelets > 100,000/μL or ANC > 1,000/μL).2

Antonio’s journey in first relapse

Every patient's journey is unique

Receives 2 cycles of BLINCYTO® induction with hospitalization at an academic medical center (requiring travel) for the first 9 days of the first cycle and the first 2 days of the second cycle, and transitions to a standalone infusion center closer to home; achieves CR and MRD negativity thereafter1

Receives 3 cycles of BLINCYTO® consolidation at a standalone infusion center1

Deemed ineligible for transplant due to poor overall health in relation to fitness and comorbidities

Receives 4 cycles of BLINCYTO® continued therapy at a standalone infusion center1

Don't wait, integrate BLINCYTO® earlier in patients with R/R disease, regardless of age§

§Indicated in adult and pediatric patients 1 month and older.2

ALL, acute lymphoblastic leukemia; ANC, absolute neutrophil count; BM, bone marrow; CD, cluster of differentiation; CI, confidence interval; CR, complete remission; CRh*, complete remission with partial hematologic recovery; CRi, complete remission with incomplete hematologic recovery; HR, hazard ratio; HSCT, allogeneic hematopoietic stem cell transplantation; MLL, mixed-lineage leukemia; MRD, measurable or minimal residual disease; OS, overall survival; Ph(–), Philadelphia chromosome–negative; SOC, standard-of-care.

References: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen. 2. Kantarjian H, Stein A, Gökbuget N, et al. Blinatumomab versus chemotherapy for advanced acute lymphoblastic leukemia. N Engl J Med. 2017;376:836-847.

BLINCYTO® data in high-risk first relapse

Amgen 2012015 study design: A randomized, controlled, open-label, phase 3 study of BLINCYTO® vs chemotherapy in 111 patients 28 days to 18 years of age with high-risk,* first-relapse, Ph(–) B-cell precursor ALL with < 25% blasts in the bone marrow after induction and 2 cycles of consolidation chemotherapy.† Patients were randomized to receive BLINCYTO®‡ or the IntReALL HR 2010 HC3 intensive combination chemotherapy§ as the third cycle of consolidation. Patients were to proceed to HSCT after this cycle of consolidation.1 Efficacy was established on the basis of OS and RFS.1

5-year KM estimates for OS1,**

78.4%

BLINCYTO® arm
(n=54)

vs

41.4%

Chemotherapy only
arm (n=57)

HR: 0.35 (95% CI: 0.17–0.70)††

5-year KM estimates for RFS1

61.1%

BLINCYTO® arm
(n=54)

vs

27.6%

Chemotherapy only
arm (n=57)

HR: 0.38 (95% CI: 0.22–0.66)††

See safety data for Amgen 2012015

*High risk was defined as very early or early iBM relapse, very early combined BM + EM relapse, or very early iEM relapse. Very early relapse was defined as < 18 months after primary diagnosis, and early relapse was defined as ≥ 18 months after primary diagnosis and < 6 months after completion of primary therapy.2

†Induction therapy and cycles of HC1 and HC2 chemotherapy, administered according to the IntReALL HR 2010, ALL-REZ BFM 2002, ALL R3, COOPRALL, and AIEOP ALL REC 2003 protocols.3

‡Patients in the BLINCYTO® arm received one cycle of BLINCYTO® as a continuous IV infusion at 15 mcg/m2/day over 4 weeks (maximum daily dose was not to exceed 28 mcg/day).1

§Third block of consolidation chemotherapy, HC3, included: dexamethasone IV/vincristine IV/daunorubicin IV/methotrexate IV/ifosfamide IV/PEG-asparaginase IV/IM.2,4

**Median follow-up time for OS was 55.2 months.1

††The hazard ratio estimates are obtained from the Cox proportional hazard model.1

Kai’s journey in first relapse

Every patient's journey is unique

Receives reinduction chemotherapy with a multiagent regimen (UKALL R3)5

Receives 1 cycle of BLINCYTO® with hospitalization at academic medical center for the first 9 days and transitions to a hospital-owned home infusion thereafter1

Undergoes evaluation for transplant eligibility and deemed a good candidate

Proceeds to HSCT

Don't wait, integrate BLINCYTO® earlier in patients with R/R disease, regardless of age‡‡

‡‡Indicated in adult and pediatric patients 1 month and older.2

ALL, acute lymphoblastic leukemia; BM, bone marrow; CD, cluster of differentiation; EM, extramedullary; HR, hazard ratio; HSCT, allogeneic hematopoietic stem cell transplantation; iBM, isolated bone marrow; iEM, isolated extramedullary; IM, intramuscular; IV, intravenous; KM, Kaplan–Meier; Ph(–), Philadelphia chromosome–negative; RFS, relapse-free survival.

References: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen. 2. Data on file, Amgen; 2020. 3. 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. 4. 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(suppl 3):843-854. 5. 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 May 2, 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.

BLINCYTO® data in frontline consolidation

E1910 study design: 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.2,3 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.2

Overall population aged 30-70 years†
5-year KM estimates for OS2

82.4%

BLINCYTO® arm
(n=112)

vs

62.5%

Chemotherapy only
arm (n=112)

HR: 0.44 (95% CI: 0.25–0.76))

See safety data for E1910

*The hazard ratio estimates are obtained from a stratified Cox regression model at the third interim analysis.2

†In a later analysis with a median follow-up of 4.5 years.2

Juan’s frontline consolidation journey

Every patient's journey is unique

Deemed ineligible for transplant due to poor overall health in relation to fitness/comorbidities and minimal support system

Receives frontline consolidation with cycles 1 and 2 of BLINCYTO® with hospitalization at an academic medical center (requiring travel) for the first 3 days of the first cycle and the first 2 days of the second cycle, and transitions to third-party independent home infusion thereafter as unable to travel due to overall health2

Receives additional frontline consolidation treatment with a multiagent regimen (mini-hyperCVD), alternating with cycles 3 and 4 of blinatumomab (BLINCYTO®) via a third-party independent home infusion1,2

Don't wait, integrate BLINCYTO® into frontline consolidation across all ages‡ regardless of chemotherapy and MRD status

‡Indicated in adult and pediatric patients 1 month and older.2

ALL, acute lymphoblastic leukemia; CD, cluster of differentiation; CI, confidence interval; CVAD, cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride (Adriamycin), methotrexate, and cytarabine; HR, hazard ratio; KM, Kaplan-Meier; MRD, measurable or minimal residual disease; OS, overall survival; Ph(–), Philadelphia chromosome–negative.

References: 1. 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. 2. BLINCYTO® (blinatumomab) prescribing information, Amgen. 3. 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.

BLINCYTO® data in frontline consolidation

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.1,*

SR-Average and SR-High
3-year DFS1,2,†

96%

BLINCYTO® arm
(n=718)

vs

87.9%

Chemotherapy only
arm (n=722)

HR: 0.39 (95% CI: 0.24–0.64);‡ P < 0.0001

SR-Average and SR-High
3-year CIR1,§

3.3%

BLINCYTO® arm
(n=718)

vs

11.8%

Chemotherapy only
arm (n=722)

See safety data for AALL1731

*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.1,3

†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. At a median follow-up of 2.5 years, 81 events had occurred.1

‡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.3

§Cumulative incidence of relapse is the estimated incidence of relapse over time.4

Mateo’s frontline consolidation journey

Every patient's journey is unique

As part of the consolidation phase of multiphase chemotherapy, receives 2 non-sequential cycles of BLINCYTO® with hospitalization at the academic medical center for the first 3 days of the first cycle and the first 2 days of the second cycle, and transitions to the hospital-owned outpatient infusion center thereafter3,5

Don't wait, integrate BLINCYTO® into frontline consolidation across all ages** regardless of chemotherapy and MRD status

**Indicated in adult and pediatric patients 1 month and older.2

ALL, acute lymphoblastic leukemia; CD, cluster of differentiation; CI, confidence interval; CIR, cumulative incidence of relapse; CNS, central nervous system; DFS, disease-free survival; HR, hazard ratio; MRD, measurable or minimal residual disease; NCI, National Cancer Institute; Ph(–), Philadelphia chromosome–negative.

References: 1. 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. 2. 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. 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 (suppl). doi:10.1056/NEJMoa2411680. 4. Brazauskas R, Eapen M, Wang T. Endpoint selection and evaluation in hematology studies. Best Pract Res Clin Haematol. 2023;36:101479. 5. BLINCYTO® (blinatumomab) prescribing information, Amgen.

BLINCYTO® data in frontline consolidation

E1910 study design: 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.2,3 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.2 MRD was assessed centrally using standardized 6-color flow cytometry, with MRD(–) defined as < 0.01% leukemic cells in the bone marrow.3

Subgroup of patients aged 30–39 years
3-year OS4

100%
BLINCYTO® arm (n=21)
vs
73%
Chemotherapy only arm (n=26)

Efficacy in this subgroup was not a prespecified study objective and the study was not powered to assess the efficacy in this subgroup.3

BLAST 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®.2

Median OS at 5 years5,‡,§,**,††

NR
MRD responders (n=84)
vs
14.4 mo
MRD nonresponders (n=23)

†The hazard ratio estimates are obtained from a stratified Cox regression model at the third interim analysis.2

‡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.5

§Patients in this population differ from the USPI population. Analysis includes additional patients: those who achieved CRh* and CRi and/or are in CR3.2,6-8

**Median follow-up for OS was 59.8 months.5

††Due to the differential effect of HSCT on OS, interpretation of the results of OS cannot exclude potential confounding of HSCT.3

Amira’s frontline consolidation journey

Every patient’s journey is unique

  • Deemed eligible for transplant but is advised not to proceed at this stage due to MRD positivity status
  • Receives 2 cycles of BLINCYTO® with hospitalization at an academic medical center for the first 3 days of the first cycle and the first 2 days of the second cycle, and transition to a community oncology clinic thereafter2
  • MRD test ordered after 2 cycles of BLINCYTO® demonstrates MRD of < 0.0001%
  • Re-evaluated for transplant eligibility and deemed eligible
  • Receives a third cycle of BLINCYTO® at the community oncology clinic while HSCT preparations are made2

Don't wait, integrate BLINCYTO® into frontline consolidation across all ages†† regardless of chemotherapy and MRD status

††Indicated in adult and pediatric patients 1 month and older.2

ALL, acute lymphoblastic leukemia; AYA, adolescent and young adult; CCR, continuous complete remission; CD, cluster of differentiation; CI, confidence interval; CR3, third complete remission; CRh*, complete remission with partial hematologic recovery; CRi, complete remission with incomplete hematologic recovery; DFCI, Dana-Farber Cancer Institute; HR, hazard ratio; HSCT, allogeneic hematopoietic stem cell transplantation; KM, Kaplan-Meier; MRD, measurable or minimal residual disease; NGS, next-generation sequencing; NR, not reached; OS, overall survival; Ph(–), Philadelphia chromosome–negative; USPI, US Prescribing Information.

References: 1. 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. 2. BLINCYTO® (blinatumomab) prescribing information, Amgen. 3. 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. 4. Dinner S, Sun Z, Paietta E, et al. Addition of blinatumomab to consolidation therapy for younger adults (< 55 years) with newly diagnosed BCR:ABL1-negative B-acute lymphoblastic leukemia (ALL) on the ECOG-ACRIN E1910 phase III trial. Presented at: 30th EHA Congress; June 12–15, 2025; Milan, Italy. 5. 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. 6. 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. 7. 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. 8. Data on file, Amgen; 2018.

BLINCYTO® data in frontline consolidation

E1910 study design: 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.2,3 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.2

Overall population aged 30-70 years2,‡
5-year KM estimates for OS

82.4%
BLINCYTO® arm (n=112)
vs
62.5%
Chemotherapy only arm (n=112)

HR: 0.44 (95% CI: 0.25–0.76)

BLAST 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®.2

Median OS at 5 years4,§,**,††

NR
MRD responders (n=84)
vs
14.4 mo
MRD nonresponders (n=23)

†The hazard ratio estimates are obtained from a stratified Cox regression model at the third interim analysis.2

‡In a later analysis with a median follow-up of 4.5 years.2

§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.4

**Median follow-up for OS was 59.8 months.4

††Patients in this population differ from the USPI population. Analysis includes additional patients: those who achieved CRh* and CRi and/or are in CR3.2,5-7

John’s frontline consolidation journey

Every patient's journey is unique

  • Deemed eligible for transplant but is advised not to proceed at this stage due to MRD positivity status
  • Receives 2 cycles of BLINCYTO® with hospitalization at the academic medical center (requiring travel) for the first 3 days of the first cycle and the first 2 days of the second cycle, and transitions to third-party independent home infusion due to preference thereafter2
  • MRD test ordered after 2 cycles of BLINCYTO® demonstrates MRD of < 0.0001%
  • Re-evaluated for transplant eligibility and deemed eligible
  • Receives a third cycle of BLINCYTO® via a third-party independent home infusion while HSCT preparations are made2

Don't wait, integrate BLINCYTO® into frontline consolidation across all ages‡‡ regardless of chemotherapy and MRD status

††Indicated in adult and pediatric patients 1 month and older.2

ALL, acute lymphoblastic leukemia; CCR, continuous complete remission; CD, cluster of differentiation; CI, confidence interval; CR3, third complete remission; CRh*, complete remission with partial hematologic recovery; CRi, complete remission with incomplete hematologic recovery; HR, hazard ratio; HSCT, allogeneic hematopoietic stem cell transplantation; KM, Kaplan-Meier; MRD, measurable or minimal residual disease; NGS, next-generation sequencing; NR, not reached; OS, overall survival; Ph(–), Philadelphia chromosome–negative; USPI, US Prescribing Information.

References: 1. 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. 2. BLINCYTO® (blinatumomab) prescribing information, Amgen. 3. 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. 4. 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. 5. 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. 6. 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. 7. Data on file, Amgen; 2018.

BLINCYTO® data in frontline consolidation

E1910 study design: 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.2,3 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.2

Overall population aged 30-70 years‡
5-year KM estimates for OS2,3

82.4%
BLINCYTO® arm (n=112)
vs
62.5%
Chemotherapy only arm (n=112)

HR: 0.44 (95% CI: 0.25–0.76)

BLAST 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®.2

Median OS at 5 years4,§,**,††

NR
MRD responders (n=84)
vs
14.4 mo
MRD nonresponders (n=23)

†The hazard ratio estimates are obtained from a stratified Cox regression model at the third interim analysis.2

‡In a later analysis with a median follow-up of 4.5 years.2

§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.4

**Patients in this population differ from the USPI population. Analysis includes additional patients: those who achieved CRh* and CRi and/or are in CR3.2,5-7

††Median follow-up for OS was 59.8 months.4

Steve's frontline consolidation journey

Every patient's journey is unique

  • Deemed ineligible for transplant due to poor overall health in relation to fitness
  • Receives 2 cycles of BLINCYTO® with hospitalization at the community hospital for the first 3 days of the first cycle and the first 2 days of the second cycle, and transition to standalone infusion center closer to home thereafter2
  • MRD test ordered after 2 cycles of BLINCYTO® demonstrates MRD of < 0.0001%
  • Receives 2 additional cycles of BLINCYTO® at standalone infusion center2

Don't wait, integrate BLINCYTO® into frontline consolidation across all ages‡‡ regardless of chemotherapy and MRD status

††Indicated in adult and pediatric patients 1 month and older.2

ALL, acute lymphoblastic leukemia; CCR, continuous complete remission; CD, cluster of differentiation; CI, confidence interval; CR3, third complete remission; CRh*, complete remission with partial hematologic recovery; CRi, complete remission with incomplete hematologic recovery; GMALL, German multicenter ALL; HR, hazard ratio; HSCT, allogeneic hematopoietic stem cell transplantation; KM, Kaplan-Meier; MRD, measurable or minimal residual disease; NGS, next-generation sequencing; NR, not reached; OS, overall survival; Ph(–), Philadelphia chromosome–negative; USPI, US Prescribing Information.

References: 1. 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. 2. BLINCYTO® (blinatumomab) prescribing information, Amgen. 3. 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. 4. 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. 5. 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. 6. 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. 7. Data on file, Amgen; 2018.

See how BLINCYTO® can help patients with CD19-positive B-cell precursor ALL regardless of age and MRD status

Answer the following questions to find hypothetical profile(s) that may represent the patients you see in your practice. You can modify your responses at any time.

Note: these profiles are modeled after patients that were seen in BLINCYTO® clinical trials. These profiles are for educational purposes only and are not intended to replace independent medical decision-making regarding your patients' individual needs.

Progress

What is the age of your patient?

Progress

What is the Philadelphia chromosome status of your patient?

Progress

What line of therapy is your patient currently in?

Progress

What is the MRD status of your patient after frontline induction?

Progress
Show questions
What is the age of your patient?

What is the Philadelphia chromosome status of your patient?

What line of therapy is your patient currently in?

What is the MRD status of your patient after frontline induction?

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 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
BACK TO TOP