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STATUS · fda-aa-da1e8cf5591121624c4f

Danyelza (naxitamab-gqgk)

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This status concerns only the indication wording below. It must not be applied to other uses of the same drug. It is not reconciled against the current label.

Exact indication

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.

Source status category
ongoing
Event date
2020-11-25
Meaning of this date
Original accelerated approval date; ongoing status observed at source retrieval
accelerated approval date
2020-11-25
accelerated approval date source text
11/25/2020
brand name hint
Danyelza
date change comparison status
no_previous_normalized_snapshot_supplied
date change from prior snapshot
Source null
drug name exact
Danyelza (naxitamab-gqgk)
generic name hint
naxitamab-gqgk
id
fda-aa-da1e8cf5591121624c4f
indication exact
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.
original projected completion source text
9/30/2027
post marketing requirement exact
3950-1: Submit the final report, including datasets, from an ongoing multicenter clinical trial to verify and further characterize the clinical benefit of naxitamab for the treatment of patients with R/R neuroblastoma in combination with GM-CSF in bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy; and to provide a more precise estimation of ORR and DOR (according to the revised International Neuroblastoma Response Criteria by blinded independent review). Enroll a minimum of 80 patients with evaluable disease and systematically follow all responding patients for at least 12 months from the onset of response, or until disease progression, whichever comes first. Include subgroup analyses of ORR and DOR by prior anti-GD2 exposure, disease status (refractory vs. relapsed disease), anti-drug antibody (ADA) status (neutralizing antibody [nAb] positive versus nAb negative, ADA positive versus ADA negative), and area of disease involvement (bone marrow vs. bone) in the final report reflecting a sufficient number of patients in relevant subgroups. Derive the clinical data from a minimum of 6 study sites, with at least 5 patients enrolled per site in at least 5 sites.
record type
fda_accelerated_approval_status_row
related fda urls
    source cells exact
    1. links
        text
        Danyelza (naxitamab-gqgk)
      1. links
          text
          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.
        1. links
            text
            11/25/2020
          1. links
              text
              3950-1: Submit the final report, including datasets, from an ongoing multicenter clinical trial to verify and further characterize the clinical benefit of naxitamab for the treatment of patients with R/R neuroblastoma in combination with GM-CSF in bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy; and to provide a more precise estimation of ORR and DOR (according to the revised International Neuroblastoma Response Criteria by blinded independent review). Enroll a minimum of 80 patients with evaluable disease and systematically follow all responding patients for at least 12 months from the onset of response, or until disease progression, whichever comes first. Include subgroup analyses of ORR and DOR by prior anti-GD2 exposure, disease status (refractory vs. relapsed disease), anti-drug antibody (ADA) status (neutralizing antibody [nAb] positive versus nAb negative, ADA positive versus ADA negative), and area of disease involvement (bone marrow vs. bone) in the final report reflecting a sufficient number of patients in relevant subgroups. Derive the clinical data from a minimum of 6 study sites, with at least 5 patients enrolled per site in at least 5 sites.
            1. links
                text
                9/30/2027
              source provenance
              bytes
              102185
              file
              /private/tmp/cancer-full-research/indications/raw/accelerated-ongoing.html
              http status
              200
              retrieved at
              2026-09-09T23:35:15.160724+00:00
              sha256
              8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
              source page date Modified text
              Wed, 09/09/2026 - 00:00
              source page date Published text
              Wed, 09/09/2026 - 12:45
              source row index
              48
              source table headers
              1. Drug Name
              2. Accelerated Approval (AA) Indication
              3. AA Date
              4. AA Post-Marketing Requirement
              5. Original Projected Completion 1
              source table index
              0
              source url
              https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
              status applies to
              This exact indication and regimen, not every use of this drug
              status category
              ongoing
              status event date
              2020-11-25
              status event date meaning
              Original accelerated approval date; ongoing status observed at source retrieval
              traditional approval date
              Source null
              verification flags
                verification status
                official_fda_status_table_extracted_indication_matching_not_clinically_reviewed
                withdrawal date
                Source null
                Source correspondence records
                matching
                drug name exact
                Danyelza (naxitamab-gqgk)
                fda status record id
                fda-aa-da1e8cf5591121624c4f
                indication exact
                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.
                match status
                source_correspondence_found_clinical_review_pending
                matched candidate ids
                1. ind-span-fb99ce9100fa6188c418
                2. ind-span-e15fcdc301ec6b81bc1b
                source provenance
                bytes
                102185
                file
                /private/tmp/cancer-full-research/indications/raw/accelerated-ongoing.html
                http status
                200
                retrieved at
                2026-09-09T23:35:15.160724+00:00
                sha256
                8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
                source page date Modified text
                Wed, 09/09/2026 - 00:00
                source page date Published text
                Wed, 09/09/2026 - 12:45
                status category
                ongoing
                unmatched meaning
                Source null
                links
                1. package id
                  fda-label-library-8184721b7b3bb86692f8276c
                  correspondence id
                  correspondence-240c17d581b0aaa22c849707
                  span id
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                  status id
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                  match method
                  whole_indication_literal_normalized_substring
                  scope relationship
                  whole_fda_indication_text_present
                  matching review status
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                  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.
                  label id
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                  offset unit
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                  source array index
                  0
                  source field
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                  source text sha256
                  3e36b568d2aa90f0caacc14b4b4b89f87bff2234ea0ee2f57699a4a22f7d9630
                  start
                  663
                  fda indication exact
                  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.
                  fda source row index
                  48
                  fda source sha256
                  8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
                  fda status record id
                  fda-aa-da1e8cf5591121624c4f
                  interpretation
                  Source wording correspondence to a dated FDA status row; current approval not certified
                  match method
                  whole_indication_literal_normalized_substring
                  matching review status
                  source_comparison_only_clinical_review_pending
                  scope relationship
                  whole_fda_indication_text_present
                  status category
                  ongoing
                  status event date
                  2020-11-25
                  supporting anchor spans
                  1. package id
                    fda-label-library-8184721b7b3bb86692f8276c
                    correspondence id
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                    span id
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                    status id
                    fda-aa-da1e8cf5591121624c4f
                    match method
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                    scope relationship
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                    matching review status
                    source_comparison_only_clinical_review_pending
                    payload
                    candidate source span
                    end
                    381
                    end exclusive
                    true
                    exact 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.
                    label id
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                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
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                    source text sha256
                    3e36b568d2aa90f0caacc14b4b4b89f87bff2234ea0ee2f57699a4a22f7d9630
                    start
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                    fda indication exact
                    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.
                    fda source row index
                    48
                    fda source sha256
                    8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
                    fda status record id
                    fda-aa-da1e8cf5591121624c4f
                    interpretation
                    Source wording correspondence to a dated FDA status row; current approval not certified
                    match method
                    whole_indication_literal_normalized_substring
                    matching review status
                    source_comparison_only_clinical_review_pending
                    scope relationship
                    whole_fda_indication_text_present
                    status category
                    ongoing
                    status event date
                    2020-11-25
                    supporting anchor spans

                    Preserved source evidence · Not medical advice