Skip to content
Triangle logo TriangleGet started
← Back to this collection

LABELS · 27169364-7492-47e7-b2f5-7dc7d20e36a7

Unituxin

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
2026-07-06
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: SERIOUS INFUSION REACTIONS AND NEUROTOXICITY WARNING: SERIOUS INFUSION REACTIONS AND NEUROTOXICITY See full prescribing information for complete boxed warning. Infusion Reactions: Life-threatening infusion adverse reactions occur with Unituxin. Administer required prehydration and premedication. Immediately interrupt for severe infusion reactions and permanently discontinue for anaphylaxis [see Dosage and Administration (2.2 , 2.3) and Warnings and Precautions (5.1) ] . Neurotoxicity: Unituxin causes severe neuropathic pain. Administer intravenous opioid prior to, during, and for 2 hours following completion of the Unituxin infusion. Severe peripheral sensory neuropathy ranged from 2% to 9% in patients with neuroblastoma. Severe peripheral motor neuropathy has also been reported. Discontinue for severe unresponsive pain, severe sensory neuropathy, and moderate to severe peripheral motor neuropathy [see Dosage and Administration (2.2 , 2.3) and Warnings and Precautions (5.2) ] . Infusion Reactions Serious and potentially life-threatening infusion reactions occurred in 26% of patients treated with Unituxin. Administer required prehydration and premedication including antihistamines prior to each Unituxin infusion. Monitor patients closely for signs and symptoms of an infusion reaction during and for at least four hours following completion of each Unituxin infusion. Immediately interrupt Unituxin for severe infusion reactions and permanently discontinue Unituxin for anaphylaxis ( 2.2, 2.3, 5.1 ). Neurotoxicity Unituxin causes serious neurologic adverse reactions including severe neuropathic pain and peripheral neuropathy. Severe neuropathic pain occurs in the majority of patients. Administer intravenous opioid prior to, during, and for 2 hours following completion of the Unituxin infusion. In clinical studies of patients with high-risk neuroblastoma, Grade 3 peripheral sensory neuropathy occurred in 2% to 9% of patients. In clinical studies of Unituxin and related GD2-binding antibodies, severe motor neuropathy has occurred. Resolution of motor neuropathy did not occur in all cases. Discontinue Unituxin for severe unresponsive pain, severe sensory neuropathy, and moderate to severe peripheral motor neuropathy ( 2.2, 2.3, 5.2 ).

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy [see Clinical Studies (14) ] . Unituxin is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. ( 1 )
Full extracted label fields
application numbers
  1. BLA125516
boxed warning exact
  1. WARNING: SERIOUS INFUSION REACTIONS AND NEUROTOXICITY WARNING: SERIOUS INFUSION REACTIONS AND NEUROTOXICITY See full prescribing information for complete boxed warning. Infusion Reactions: Life-threatening infusion adverse reactions occur with Unituxin. Administer required prehydration and premedication. Immediately interrupt for severe infusion reactions and permanently discontinue for anaphylaxis [see Dosage and Administration (2.2 , 2.3) and Warnings and Precautions (5.1) ] . Neurotoxicity: Unituxin causes severe neuropathic pain. Administer intravenous opioid prior to, during, and for 2 hours following completion of the Unituxin infusion. Severe peripheral sensory neuropathy ranged from 2% to 9% in patients with neuroblastoma. Severe peripheral motor neuropathy has also been reported. Discontinue for severe unresponsive pain, severe sensory neuropathy, and moderate to severe peripheral motor neuropathy [see Dosage and Administration (2.2 , 2.3) and Warnings and Precautions (5.2) ] . Infusion Reactions Serious and potentially life-threatening infusion reactions occurred in 26% of patients treated with Unituxin. Administer required prehydration and premedication including antihistamines prior to each Unituxin infusion. Monitor patients closely for signs and symptoms of an infusion reaction during and for at least four hours following completion of each Unituxin infusion. Immediately interrupt Unituxin for severe infusion reactions and permanently discontinue Unituxin for anaphylaxis ( 2.2, 2.3, 5.1 ). Neurotoxicity Unituxin causes serious neurologic adverse reactions including severe neuropathic pain and peripheral neuropathy. Severe neuropathic pain occurs in the majority of patients. Administer intravenous opioid prior to, during, and for 2 hours following completion of the Unituxin infusion. In clinical studies of patients with high-risk neuroblastoma, Grade 3 peripheral sensory neuropathy occurred in 2% to 9% of patients. In clinical studies of Unituxin and related GD2-binding antibodies, severe motor neuropathy has occurred. Resolution of motor neuropathy did not occur in all cases. Discontinue Unituxin for severe unresponsive pain, severe sensory neuropathy, and moderate to severe peripheral motor neuropathy ( 2.2, 2.3, 5.2 ).
brand names
  1. Unituxin
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d66bdf0d-9d65-45de-ae5b-a58617c27492
generic names
  1. DINUTUXIMAB
id
27169364-7492-47e7-b2f5-7dc7d20e36a7
indications and usage exact
  1. 1 INDICATIONS AND USAGE Unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy [see Clinical Studies (14) ] . Unituxin is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. ( 1 )
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. United Therapeutics Corporation
    matched search terms
    1. neuroblastoma
    package ndcs
    1. 66302-014-01
    product ndcs
    1. 66302-014
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Dosage and Administration ( 2.3 ) 10/2025
    record type
    complete_spl_indications_section_candidate
    routes
    1. INTRAVENOUS
    rxcuis
    1. 1606278
    2. 1606283
    source batch
    file
    /private/tmp/cancer-full-research/indications/raw/labels-00100.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
    results
    limit
    100
    skip
    100
    total
    830
    sha256
    fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
    url
    https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=100&sort=id%3Aasc
    source url
    https://api.fda.gov/drug/label.json?search=id%3A%2227169364-7492-47e7-b2f5-7dc7d20e36a7%22
    spl effective date
    2026-07-06
    spl effective time
    20260706
    spl set id
    d66bdf0d-9d65-45de-ae5b-a58617c27492
    spl version
    17
    substance names
    1. DINUTUXIMAB
    uniis
    1. 7SQY4ZUD30
    verification flags
    1. oncology_keyword_candidate_not_clinically_classified
    2. spl_text_not_verified_identical_to_latest_approved_label
    3. individual_indications_not_split_or_reconciled
    Drugs@FDA application source records
    1. application number
      BLA125516
      payload
      all indexed label documents
      1. Appl No
        125516
        Application Docs Date
        2015-03-10 00:00:00
        Application Docs ID
        39985
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        ORIG
      2. Appl No
        125516
        Application Docs Date
        2017-03-02 00:00:00
        Application Docs ID
        47388
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        11
        Submission Type
        SUPPL
      3. Appl No
        125516
        Application Docs Date
        2020-10-01 00:00:00
        Application Docs ID
        64775
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        25
        Submission Type
        SUPPL
      4. Appl No
        125516
        Application Docs Date
        2025-10-10 00:00:00
        Application Docs ID
        83746
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        41
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        125516
        Review Priority
        PRIORITY
        Submission Class Code ID
        7
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2015-03-10 00:00:00
        Submission Type
        ORIG
        Submissions Public Notes
      2. Appl No
        125516
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        11
        Submission Status
        AP
        Submission Status Date
        2017-03-01 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        125516
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        25
        Submission Status
        AP
        Submission Status Date
        2020-09-29 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      4. Appl No
        125516
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        41
        Submission Status
        AP
        Submission Status Date
        2025-10-10 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      application number
      BLA125516
      approval interpretation
      Application linkage and approved submission are not indication-level current approval verification
      current indication status
      not_reconciled
      has approved submission record
      true
      latest approved submission date
      2025-10-10
      latest label selection rule
      max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
      latest posted label documents
      1. Appl No
        125516
        Application Docs Date
        2025-10-10 00:00:00
        Application Docs ID
        83746
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        41
        Submission Type
        SUPPL
      official application record
      Appl No
      125516
      Appl Public Notes
      Appl Type
      BLA
      Sponsor Name
      UNITED THERAP
      openfda application present
      true
      products
      1. Active Ingredient
        DINUTUXIMAB
        Appl No
        125516
        Drug Name
        UNITUXIN
        Form
        INJECTABLE;INTRAVENOUS
        Product No
        001
        Reference Drug
        0
        Reference Standard
        Strength
        17.5MG/5ML
        marketing status
        1. 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
    1. BLA125516
    brand names
    1. Unituxin
    classification reasons
    1. explicit_positive_indication_predicate
    2. tumor_or_malignant_hematology_words_in_positive_statement
    clinical review status
    pending
    content role
    positive_indication_candidate
    context span
    end
    586
    end exclusive
    true
    exact text
    1 INDICATIONS AND USAGE Unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy [see Clinical Studies (14) ] . Unituxin is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the tr
    label id
    27169364-7492-47e7-b2f5-7dc7d20e36a7
    offset unit
    unicode_code_points
    source array index
    0
    source field
    indications_and_usage_exact
    source text sha256
    b6c4598181346046b1920472df7988f2de949e1fd20487a8aef445e46d0b17cb
    start
    0
    current approval status
    not_reconciled
    duplicate text group
    dup-16668b511f63cf41c6f3
    extraction review status
    automated_candidate_pending_source_review
    generic names
    1. DINUTUXIMAB
    id
    ind-span-f7feda52611a0b0c1cc6
    label id
    27169364-7492-47e7-b2f5-7dc7d20e36a7
    positive predicate support span
    end
    59
    end exclusive
    true
    exact text
    is indicated
    label id
    27169364-7492-47e7-b2f5-7dc7d20e36a7
    offset unit
    unicode_code_points
    source array index
    0
    source field
    indications_and_usage_exact
    source text sha256
    b6c4598181346046b1920472df7988f2de949e1fd20487a8aef445e46d0b17cb
    start
    47
    qualifier mentions
    1. context exact
      (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial
      kind
      age
      polarity
      not_inferred
      span
      end
      232
      end exclusive
      true
      exact text
      pediatric patients
      label id
      27169364-7492-47e7-b2f5-7dc7d20e36a7
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      b6c4598181346046b1920472df7988f2de949e1fd20487a8aef445e46d0b17cb
      start
      214
    2. context exact
      imulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neu
      kind
      biomarker
      polarity
      not_inferred
      span
      end
      191
      end exclusive
      true
      exact text
      retinoic acid (RA)
      label id
      27169364-7492-47e7-b2f5-7dc7d20e36a7
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      b6c4598181346046b1920472df7988f2de949e1fd20487a8aef445e46d0b17cb
      start
      173
    3. context exact
      roblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy [see Clinical Studies (14) ] .
      kind
      prior_therapy_or_line
      polarity
      not_inferred
      span
      end
      385
      end exclusive
      true
      exact text
      first-line multiagent, multimodality therapy [see Clinical Studies (14) ]
      label id
      27169364-7492-47e7-b2f5-7dc7d20e36a7
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      b6c4598181346046b1920472df7988f2de949e1fd20487a8aef445e46d0b17cb
      start
      311
    4. context exact
      INDICATIONS AND USAGE Unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial respons
      kind
      regimen
      polarity
      not_inferred
      span
      end
      240
      end exclusive
      true
      exact text
      in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with hi
      label id
      27169364-7492-47e7-b2f5-7dc7d20e36a7
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      b6c4598181346046b1920472df7988f2de949e1fd20487a8aef445e46d0b17cb
      start
      61
    regulatory links
      schema version
      0.1.0
      source batch sha256
      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
      source defined aliases
        source span
        end
        386
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE Unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy [see Clinical Studies (14) ] .
        label id
        27169364-7492-47e7-b2f5-7dc7d20e36a7
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        b6c4598181346046b1920472df7988f2de949e1fd20487a8aef445e46d0b17cb
        start
        0
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%2227169364-7492-47e7-b2f5-7dc7d20e36a7%22
        spl effective date
        2026-07-06
        spl set id
        d66bdf0d-9d65-45de-ae5b-a58617c27492
        spl version
        17
        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
        Passage 2 · positive indication candidate
        application numbers
        1. BLA125516
        brand names
        1. Unituxin
        classification reasons
        1. explicit_positive_indication_predicate
        2. tumor_or_malignant_hematology_words_in_positive_statement
        clinical review status
        pending
        content role
        positive_indication_candidate
        context span
        end
        745
        end exclusive
        true
        exact text
        (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy [see Clinical Studies (14) ] . Unituxin is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. ( 1 )
        label id
        27169364-7492-47e7-b2f5-7dc7d20e36a7
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        b6c4598181346046b1920472df7988f2de949e1fd20487a8aef445e46d0b17cb
        start
        187
        current approval status
        not_reconciled
        duplicate text group
        dup-9235b9a31136e2920214
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. DINUTUXIMAB
        id
        ind-span-e0282ab44e7f0265777a
        label id
        27169364-7492-47e7-b2f5-7dc7d20e36a7
        positive predicate support span
        end
        442
        end exclusive
        true
        exact text
        is a GD2-binding monoclonal antibody indicated
        label id
        27169364-7492-47e7-b2f5-7dc7d20e36a7
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        b6c4598181346046b1920472df7988f2de949e1fd20487a8aef445e46d0b17cb
        start
        396
        qualifier mentions
        1. context exact
          (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial
          kind
          age
          polarity
          not_inferred
          span
          end
          615
          end exclusive
          true
          exact text
          pediatric patients
          label id
          27169364-7492-47e7-b2f5-7dc7d20e36a7
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          b6c4598181346046b1920472df7988f2de949e1fd20487a8aef445e46d0b17cb
          start
          597
        2. context exact
          imulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neu
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          574
          end exclusive
          true
          exact text
          retinoic acid (RA)
          label id
          27169364-7492-47e7-b2f5-7dc7d20e36a7
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          b6c4598181346046b1920472df7988f2de949e1fd20487a8aef445e46d0b17cb
          start
          556
        3. context exact
          roblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.
          kind
          prior_therapy_or_line
          polarity
          not_inferred
          span
          end
          738
          end exclusive
          true
          exact text
          first-line multiagent, multimodality therapy
          label id
          27169364-7492-47e7-b2f5-7dc7d20e36a7
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          b6c4598181346046b1920472df7988f2de949e1fd20487a8aef445e46d0b17cb
          start
          694
        4. context exact
          Unituxin is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial respons
          kind
          regimen
          polarity
          not_inferred
          span
          end
          623
          end exclusive
          true
          exact text
          in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with hi
          label id
          27169364-7492-47e7-b2f5-7dc7d20e36a7
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          b6c4598181346046b1920472df7988f2de949e1fd20487a8aef445e46d0b17cb
          start
          444
        regulatory links
          schema version
          0.1.0
          source batch sha256
          fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
          source defined aliases
            source span
            end
            739
            end exclusive
            true
            exact text
            Unituxin is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.
            label id
            27169364-7492-47e7-b2f5-7dc7d20e36a7
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            b6c4598181346046b1920472df7988f2de949e1fd20487a8aef445e46d0b17cb
            start
            387
            source url
            https://api.fda.gov/drug/label.json?search=id%3A%2227169364-7492-47e7-b2f5-7dc7d20e36a7%22
            spl effective date
            2026-07-06
            spl set id
            d66bdf0d-9d65-45de-ae5b-a58617c27492
            spl version
            17
            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
            Passage 3 · unclassified context
            application numbers
            1. BLA125516
            brand names
            1. Unituxin
            classification reasons
            1. no_unambiguous_positive_indication_predicate
            clinical review status
            pending
            content role
            unclassified_context
            context span
            end
            745
            end exclusive
            true
            exact text
            -2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. ( 1 )
            label id
            27169364-7492-47e7-b2f5-7dc7d20e36a7
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            b6c4598181346046b1920472df7988f2de949e1fd20487a8aef445e46d0b17cb
            start
            540
            current approval status
            not_reconciled
            duplicate text group
            dup-ff656cc30716e2b135c2
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. DINUTUXIMAB
            id
            ind-span-bc38ad0fd49d539f3569
            label id
            27169364-7492-47e7-b2f5-7dc7d20e36a7
            positive predicate support span
            Source null
            qualifier mentions
              regulatory links
                schema version
                0.1.0
                source batch sha256
                fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                source defined aliases
                  source span
                  end
                  745
                  end exclusive
                  true
                  exact text
                  ( 1 )
                  label id
                  27169364-7492-47e7-b2f5-7dc7d20e36a7
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  b6c4598181346046b1920472df7988f2de949e1fd20487a8aef445e46d0b17cb
                  start
                  740
                  source url
                  https://api.fda.gov/drug/label.json?search=id%3A%2227169364-7492-47e7-b2f5-7dc7d20e36a7%22
                  spl effective date
                  2026-07-06
                  spl set id
                  d66bdf0d-9d65-45de-ae5b-a58617c27492
                  spl version
                  17
                  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