LABELS · 5878035d-081a-1653-e063-6394a90af965

DANYELZA

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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: 2026-08-07
Captured: 2026-09-09T23:37:47.659725+00:00
Current indication reconciliation: Not reconciled

Boxed warning in this label

WARNING: SERIOUS INFUSION-RELATED REACTIONS and NEUROTOXICITY WARNING: SERIOUS INFUSION-RELATED REACTIONS and NEUROTOXICITY See full prescribing information for complete boxed warning Serious Infusion-Related Reactions: DANYELZA can cause serious infusion reactions, including cardiac arrest, anaphylaxis, hypotension, bronchospasm, and stridor. Premedicate prior to each DANYELZA infusion as recommended. Reduce the rate, interrupt infusion, or permanently discontinue DANYELZA based on severity ( 2.2 , 2.3 , 4 , 5.1 ). Neurotoxicity: DANYELZA can cause severe neurotoxicity, including severe neuropathic pain, transverse myelitis, and reversible posterior leukoencephalopathy syndrome (RPLS). Premedicate to treat neuropathic pain as recommended. Permanently discontinue DANYELZA based on the adverse reaction and severity ( 2.2 , 2.3 , 5.2 ). Serious Infusion-Related Reactions DANYELZA can cause serious infusion reactions, including cardiac arrest, anaphylaxis, hypotension, bronchospasm, and stridor. Infusion reactions of any Grade occurred in 94-100% of patients. Severe infusion reactions occurred in 32-68% and serious infusion reactions occurred in 4 - 18% of patients in DANYELZA clinical studies [see Warnings and Precautions (5.1) ]. Premedicate prior to each DANYELZA infusion as recommended and monitor patients for at least 2 hours following completion of each infusion. Reduce the rate, interrupt infusion, or permanently discontinue DANYELZA based on severity [see Dosage and Administration (2.2 , 2.3) , Contraindications (4) , and Warnings and Precautions (5.1) ]. Neurotoxicity DANYELZA can cause severe neurotoxicity, including severe neuropathic pain, transverse myelitis and reversible posterior leukoencephalopathy syndrome (RPLS). Pain of any Grade occurred in 94-100% of patients in DANYELZA clinical studies [see Warnings and Precautions (5.2) ]. Premedicate to treat neuropathic pain as recommended. Permanently discontinue DANYELZA based on the adverse reaction and severity [see Dosage and Administration (2.2 , 2.3) and Warnings and Precautions (5.2) ].

Indications and usage: exact source text

1 INDICATIONS AND USAGE DANYELZA is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). DANYELZA is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )

Full extracted label fields

application numbers

BLA761171

boxed warning exact

WARNING: SERIOUS INFUSION-RELATED REACTIONS and NEUROTOXICITY WARNING: SERIOUS INFUSION-RELATED REACTIONS and NEUROTOXICITY See full prescribing information for complete boxed warning Serious Infusion-Related Reactions: DANYELZA can cause serious infusion reactions, including cardiac arrest, anaphylaxis, hypotension, bronchospasm, and stridor. Premedicate prior to each DANYELZA infusion as recommended. Reduce the rate, interrupt infusion, or permanently discontinue DANYELZA based on severity ( 2.2 , 2.3 , 4 , 5.1 ). Neurotoxicity: DANYELZA can cause severe neurotoxicity, including severe neuropathic pain, transverse myelitis, and reversible posterior leukoencephalopathy syndrome (RPLS). Premedicate to treat neuropathic pain as recommended. Permanently discontinue DANYELZA based on the adverse reaction and severity ( 2.2 , 2.3 , 5.2 ). Serious Infusion-Related Reactions DANYELZA can cause serious infusion reactions, including cardiac arrest, anaphylaxis, hypotension, bronchospasm, and stridor. Infusion reactions of any Grade occurred in 94-100% of patients. Severe infusion reactions occurred in 32-68% and serious infusion reactions occurred in 4 - 18% of patients in DANYELZA clinical studies [see Warnings and Precautions (5.1) ]. Premedicate prior to each DANYELZA infusion as recommended and monitor patients for at least 2 hours following completion of each infusion. Reduce the rate, interrupt infusion, or permanently discontinue DANYELZA based on severity [see Dosage and Administration (2.2 , 2.3) , Contraindications (4) , and Warnings and Precautions (5.1) ]. Neurotoxicity DANYELZA can cause severe neurotoxicity, including severe neuropathic pain, transverse myelitis and reversible posterior leukoencephalopathy syndrome (RPLS). Pain of any Grade occurred in 94-100% of patients in DANYELZA clinical studies [see Warnings and Precautions (5.2) ]. Premedicate to treat neuropathic pain as recommended. Permanently discontinue DANYELZA based on the adverse reaction and severity [see Dosage and Administration (2.2 , 2.3) and Warnings and Precautions (5.2) ].

brand names

DANYELZA

current indication status

not_reconciled

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generic names

NAXITAMAB

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1 INDICATIONS AND USAGE DANYELZA is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). DANYELZA is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )

indications and usage tables exact

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BTG International Inc.

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1 INDICATIONS AND USAGE DANYELZA is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.
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2020-11-25
supporting anchor spans

schema version

0.1.0

source batch sha256

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source defined aliases

source span

end: 1054
end exclusive: true
exact text: DANYELZA is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.
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source text sha256: 3e36b568d2aa90f0caacc14b4b4b89f87bff2234ea0ee2f57699a4a22f7d9630
start: 663

source url

https://api.fda.gov/drug/label.json?search=id%3A%225878035d-081a-1653-e063-6394a90af965%22

spl effective date

2026-08-07

spl set id

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spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

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

Read indication-specific status → · whole_fda_indication_text_present

Passage 5 · approval contingency

application numbers

BLA761171

brand names

DANYELZA

classification reasons

approval_contingency_words

clinical review status

pending

content role

approval_contingency

context span

end: 1311
end exclusive: true
exact text: d older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )
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source text sha256: 3e36b568d2aa90f0caacc14b4b4b89f87bff2234ea0ee2f57699a4a22f7d9630
start: 855

current approval status

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NAXITAMAB

ind-span-d1fb9df52efb342fc38b

label id

5878035d-081a-1653-e063-6394a90af965

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

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end: 1166
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exact text: This indication is approved under accelerated approval based on overall response rate and duration of response.
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source text sha256: 3e36b568d2aa90f0caacc14b4b4b89f87bff2234ea0ee2f57699a4a22f7d9630
start: 1055

source url

https://api.fda.gov/drug/label.json?search=id%3A%225878035d-081a-1653-e063-6394a90af965%22

spl effective date

2026-08-07

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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

not_applicable

Passage 6 · approval contingency

application numbers

BLA761171

brand names

DANYELZA

classification reasons

approval_contingency_words

clinical review status

pending

content role

approval_contingency

context span

end: 1311
end exclusive: true
exact text: ve demonstrated a partial response, minor response, or stable disease to prior therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )
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5878035d-081a-1653-e063-6394a90af965

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

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exact text: Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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source text sha256: 3e36b568d2aa90f0caacc14b4b4b89f87bff2234ea0ee2f57699a4a22f7d9630
start: 1167

source url

https://api.fda.gov/drug/label.json?search=id%3A%225878035d-081a-1653-e063-6394a90af965%22

spl effective date

2026-08-07

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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

not_applicable

Passage 7 · unclassified context

application numbers

BLA761171

brand names

DANYELZA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1311
end exclusive: true
exact text: val based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )
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offset unit: unicode_code_points
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source text sha256: 3e36b568d2aa90f0caacc14b4b4b89f87bff2234ea0ee2f57699a4a22f7d9630
start: 1106

current approval status

not_reconciled

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dup-263cdceb5e4194893f33

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automated_candidate_pending_source_review

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NAXITAMAB

ind-span-fcd8c29ff8f819e0194d

label id

5878035d-081a-1653-e063-6394a90af965

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 1311
end exclusive: true
exact text: ( 1 )
label id: 5878035d-081a-1653-e063-6394a90af965
offset unit: unicode_code_points
source array index: 0
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source text sha256: 3e36b568d2aa90f0caacc14b4b4b89f87bff2234ea0ee2f57699a4a22f7d9630
start: 1306

source url

https://api.fda.gov/drug/label.json?search=id%3A%225878035d-081a-1653-e063-6394a90af965%22

spl effective date

2026-08-07

spl set id

b0f5ee96-369f-4cb9-a783-3bfa70fe8f90

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

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

unclear

Preserved source evidence · Not medical advice