LABELS · 4a2c4b49-a991-4ac7-80b3-4b2f8f62de30

BLINCYTO

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2026-04-14
Captured: 2026-09-09T23:37:44.904352+00:00
Current indication reconciliation: Not reconciled

Boxed warning in this label

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 [see Dosage and Administration (2.4) , Warnings and Precautions (5.1) ] . 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 [see Dosage and Administration (2.4) , Warnings and Precautions (5.2) ] . WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning. 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. ( 2.4 , 5.1 ) 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. ( 2.4 , 5.2 )

Indications and usage: exact source text

1 INDICATIONS AND USAGE BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with: 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%. ( 1.1 ) Relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). ( 1.2 ) CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy. ( 1.3 ) 1.1 MRD-positive B-cell Precursor ALL BLINCYTO 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 one month and older. 1.2 Relapsed or Refractory B-cell Precursor ALL BLINCYTO is indicated for the treatment of relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients one month and older. 1.3 B-cell Precursor ALL in the Consolidation Phase BLINCYTO is indicated for the treatment of CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy in adult and pediatric patients one month and older.

Full extracted label fields

application numbers

BLA125557

boxed warning exact

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 [see Dosage and Administration (2.4) , Warnings and Precautions (5.1) ] . 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 [see Dosage and Administration (2.4) , Warnings and Precautions (5.2) ] . WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning. 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. ( 2.4 , 5.1 ) 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. ( 2.4 , 5.2 )

brand names

BLINCYTO

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=38b482a8-960b-4591-9857-5031ecb830aa

generic names

BLINATUMOMAB

4a2c4b49-a991-4ac7-80b3-4b2f8f62de30

indications and usage exact

1 INDICATIONS AND USAGE BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with: 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%. ( 1.1 ) Relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). ( 1.2 ) CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy. ( 1.3 ) 1.1 MRD-positive B-cell Precursor ALL BLINCYTO 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 one month and older. 1.2 Relapsed or Refractory B-cell Precursor ALL BLINCYTO is indicated for the treatment of relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients one month and older. 1.3 B-cell Precursor ALL in the Consolidation Phase BLINCYTO is indicated for the treatment of CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy in adult and pediatric patients one month and older.

indications and usage tables exact

is original packager

true

manufacturer names

Amgen, Inc

matched search terms

leukemia

package ndcs

55513-160-01
55513-160-21
55513-150-01
55513-155-01

product ndcs

55513-160

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Dosage and Administration ( 2.1 , 2.2 , 2.3 ) 12/2024 Dosage and Administration ( 2.4 , 2.5 , 2.6 ) 12/2024 Warnings and Precautions, Cytokine Release Syndrome ( 5.1 ) 10/2025 Warnings and Precautions, Neurological Toxicities including Immune Effector Cell-Associated Neurotoxicity ( 5.2 ) 4/2025 Warnings and Precautions, Benzyl Alcohol Toxicity in Neonates ( 5.12 ) 12/2024

record type

complete_spl_indications_section_candidate

routes

rxcuis

1597262
1597267

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00200.json

meta

disclaimer

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.

last updated

2026-09-09

license

https://open.fda.gov/license/

results

limit: 100
skip: 200
total: 830

terms

https://open.fda.gov/terms/

sha256

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url

source url

https://api.fda.gov/drug/label.json?search=id%3A%224a2c4b49-a991-4ac7-80b3-4b2f8f62de30%22

spl effective date

2026-04-14

spl effective time

20260414

spl set id

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spl version

substance names

uniis

verification flags

oncology_keyword_candidate_not_clinically_classified
spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled

Drugs@FDA application source records

application number
BLA125557
payload
all indexed label documents
Appl No
125557
Application Docs Date
2014-12-03 00:00:00
Application Docs ID
39995
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125557lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
125557
Application Docs Date
2016-08-30 00:00:00
Application Docs ID
45207
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125557s005s006lbl.pdf
Submission No
5
Submission Type
SUPPL
Appl No
125557
Application Docs Date
2016-08-30 00:00:00
Application Docs ID
45208
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125557s005s006lbl.pdf
Submission No
6
Submission Type
SUPPL
Appl No
125557
Application Docs Date
2017-05-05 00:00:00
Application Docs ID
48244
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s007lbl.pdf
Submission No
7
Submission Type
SUPPL
Appl No
125557
Application Docs Date
2017-07-12 00:00:00
Application Docs ID
48952
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s008lbl.pdf
Submission No
8
Submission Type
SUPPL
Appl No
125557
Application Docs Date
2017-12-01 00:00:00
Application Docs ID
50548
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s012lbl.pdf
Submission No
12
Submission Type
SUPPL
Appl No
125557
Application Docs Date
2018-03-29 00:00:00
Application Docs ID
53544
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125557s013lbl.pdf
Submission No
13
Submission Type
SUPPL
Appl No
125557
Application Docs Date
2019-04-24 00:00:00
Application Docs ID
58377
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125557s015s016lbl.pdf
Submission No
16
Submission Type
SUPPL
Appl No
125557
Application Docs Date
2019-04-24 00:00:00
Application Docs ID
58378
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125557s015s016lbl.pdf
Submission No
15
Submission Type
SUPPL
Appl No
125557
Application Docs Date
2020-03-23 00:00:00
Application Docs ID
62221
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125557s017lbl.pdf
Submission No
17
Submission Type
SUPPL
Appl No
125557
Application Docs Date
2021-03-12 00:00:00
Application Docs ID
66754
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125557s020lbl.pdf
Submission No
20
Submission Type
SUPPL
Appl No
125557
Application Docs Date
2022-02-22 00:00:00
Application Docs ID
70195
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125557s021lbl.pdf
Submission No
21
Submission Type
SUPPL
all submission records
Appl No
125557
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
32
Submission Status
AP
Submission Status Date
2025-10-21 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
125557
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
31
Submission Status
AP
Submission Status Date
2025-04-29 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
125557
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
30
Submission Status
AP
Submission Status Date
2024-12-17 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
125557
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
29
Submission Status
AP
Submission Status Date
2024-02-08 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
125557
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
28
Submission Status
AP
Submission Status Date
2024-06-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
125557
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
26
Submission Status
AP
Submission Status Date
2023-06-20 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
125557
Review Priority
N/A
Submission Class Code ID
21
Submission No
25
Submission Status
AP
Submission Status Date
2022-12-05 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
125557
Review Priority
UNKNOWN
Submission Class Code ID
2
Submission No
23
Submission Status
AP
Submission Status Date
2023-06-20 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
125557
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
21
Submission Status
AP
Submission Status Date
2022-02-18 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
125557
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
20
Submission Status
AP
Submission Status Date
2021-03-11 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
125557
Review Priority
N/A
Submission Class Code ID
21
Submission No
19
Submission Status
AP
Submission Status Date
2021-03-11 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
125557
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
18
Submission Status
AP
Submission Status Date
2021-03-11 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
BLA125557
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125557
has approved submission record
true
latest approved submission date
2025-10-21
latest label selection rule
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latest posted label documents
Appl No
125557
Application Docs Date
2025-10-22 00:00:00
Application Docs ID
83867
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125557s032lbl.pdf
Submission No
32
Submission Type
SUPPL
official application record
Appl No
125557
Appl Public Notes
Appl Type
BLA
Sponsor Name
AMGEN
openfda application present
true
products
Active Ingredient
BLINATUMOMAB
Appl No
125557
Drug Name
BLINCYTO
Form
INJECTABLE;INJECTION
Product No
001
Reference Drug
0
Reference Standard
Strength
35MCG
marketing status
Prescription

Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · positive indication candidate

application numbers

BLA125557

brand names

BLINCYTO

classification reasons

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tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

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content role

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generic names

BLINATUMOMAB

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kind
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exact text
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regulatory links

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source url

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spl effective date

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spl set id

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spl version

structured fields status

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structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

tumor_directed_candidate

Passage 2 · unclassified context

application numbers

BLA125557

brand names

BLINCYTO

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

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content role

unclassified_context

context span

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exact text: ts one month and older with: 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%. ( 1.1 ) Relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). ( 1.2 ) CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy. ( 1.3 ) 1.1 MRD-positive B-cell Precu
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positive predicate support span

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qualifier mentions

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source defined aliases

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source url

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Passage 4 · unclassified context

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exact text: r acute lymphoblastic leukemia (ALL). ( 1.2 ) CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy. ( 1.3 ) 1.1 MRD-positive B-cell Precursor ALL BLINCYTO is indicated for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal r
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Passage 5 · positive indication candidate

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exact text: lymphoblastic leukemia (ALL). ( 1.2 ) CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy. ( 1.3 ) 1.1 MRD-positive B-cell Precursor ALL BLINCYTO 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 one month and older. 1.2 Relapsed or Refractory B-cell Precursor ALL BLINCYTO is indicated for the treatment of relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediat
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exact text: 1.1 MRD-positive B-cell Precursor ALL BLINCYTO 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 one month and older.
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source url

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use intent

tumor_directed_candidate

Passage 6 · positive indication candidate

application numbers

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exact text: ecursor 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 one month and older. 1.2 Relapsed or Refractory B-cell Precursor ALL BLINCYTO is indicated for the treatment of relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients one month and older. 1.3 B-cell Precursor ALL in the Consolidation Phase BLINCYTO is indicated for the treatment of CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in th
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exact text: 1.2 Relapsed or Refractory B-cell Precursor ALL BLINCYTO is indicated for the treatment of relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients one month and older.
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source url

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use intent

tumor_directed_candidate

Passage 7 · positive indication candidate

application numbers

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brand names

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exact text: Precursor ALL BLINCYTO is indicated for the treatment of relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients one month and older. 1.3 B-cell Precursor ALL in the Consolidation Phase BLINCYTO is indicated for the treatment of CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy in adult and pediatric patients one month and older.
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exact text: 1.3 B-cell Precursor ALL in the Consolidation Phase BLINCYTO is indicated for the treatment of CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy in adult and pediatric patients one month and older.
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source url

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spl effective date

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structured indication

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limitations: Source null
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tumor histology: Source null

use intent

tumor_directed_candidate

Preserved source evidence · Not medical advice