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

LABELS · 777005ee-d019-4976-abb4-b998cf68e05f

BIZENGRI

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
2026-05-19
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: EMBRYO-FETAL TOXICITY Embryo-Fetal Toxicity: Exposure to BIZENGRI during pregnancy can cause embryo-fetal harm. Advise patients of this risk and the need for effective contraception [see Warnings and Precautions (5.4) , Use in Specific Populations (8.1 , 8.3) ]. WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Embryo-Fetal Toxicity: Exposure to BIZENGRI during pregnancy can cause embryo-fetal harm. Advise patients of this risk and the need for effective contraception [see Warnings and Precautions (5.4) , Use in Specific Populations (8.1 , 8.3) ].

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE BIZENGRI® is a bispecific HER2- and HER3-directed antibody indicated for the treatment of: Adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.1 ) Adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.2 ) Adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy. ( 1.3 ) *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). 1.1 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Non-Small Cell Lung Cancer BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.2 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Pancreatic Adenocarcinoma BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.3 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Cholangiocarcinoma BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.
Full extracted label fields
application numbers
  1. BLA761352
boxed warning exact
  1. WARNING: EMBRYO-FETAL TOXICITY Embryo-Fetal Toxicity: Exposure to BIZENGRI during pregnancy can cause embryo-fetal harm. Advise patients of this risk and the need for effective contraception [see Warnings and Precautions (5.4) , Use in Specific Populations (8.1 , 8.3) ]. WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Embryo-Fetal Toxicity: Exposure to BIZENGRI during pregnancy can cause embryo-fetal harm. Advise patients of this risk and the need for effective contraception [see Warnings and Precautions (5.4) , Use in Specific Populations (8.1 , 8.3) ].
brand names
  1. BIZENGRI
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=203daea4-fc87-40a4-a92f-ba2351b16de1
generic names
  1. ZENOCUTUZUMAB
id
777005ee-d019-4976-abb4-b998cf68e05f
indications and usage exact
  1. 1 INDICATIONS AND USAGE BIZENGRI® is a bispecific HER2- and HER3-directed antibody indicated for the treatment of: Adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.1 ) Adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.2 ) Adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy. ( 1.3 ) *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). 1.1 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Non-Small Cell Lung Cancer BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.2 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Pancreatic Adenocarcinoma BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.3 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Cholangiocarcinoma BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Partner Therapeutics, Inc.
    matched search terms
    1. cancer
    package ndcs
    1. 71837-1000-1
    2. 71837-1000-2
    product ndcs
    1. 71837-1000
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Indications and Usage ( 1.3 ) 05/2026
    record type
    complete_spl_indications_section_candidate
    routes
    1. INTRAVENOUS
    rxcuis
    1. 2699594
    2. 2699601
    source batch
    file
    /private/tmp/cancer-full-research/indications/raw/labels-00400.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
    400
    total
    830
    sha256
    a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
    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=400&sort=id%3Aasc
    source url
    https://api.fda.gov/drug/label.json?search=id%3A%22777005ee-d019-4976-abb4-b998cf68e05f%22
    spl effective date
    2026-05-19
    spl effective time
    20260519
    spl set id
    203daea4-fc87-40a4-a92f-ba2351b16de1
    spl version
    3
    substance names
    1. ZENOCUTUZUMAB
    uniis
    1. AE72RB1W1X
    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
      BLA761352
      payload
      all indexed label documents
      1. Appl No
        761352
        Application Docs Date
        2024-12-04 00:00:00
        Application Docs ID
        80507
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        ORIG
      2. Appl No
        761352
        Application Docs Date
        2026-05-18 00:00:00
        Application Docs ID
        85948
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        10
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        761352
        Review Priority
        PRIORITY
        Submission Class Code ID
        2
        Submission No
        10
        Submission Status
        AP
        Submission Status Date
        2026-05-08 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      2. Appl No
        761352
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2025-01-31 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        761352
        Review Priority
        PRIORITY
        Submission Class Code ID
        7
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2024-12-04 00:00:00
        Submission Type
        ORIG
        Submissions Public Notes
      application number
      BLA761352
      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
      2026-05-08
      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
        761352
        Application Docs Date
        2026-05-18 00:00:00
        Application Docs ID
        85948
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        10
        Submission Type
        SUPPL
      official application record
      Appl No
      761352
      Appl Public Notes
      Appl Type
      BLA
      Sponsor Name
      MERUS N.V.
      openfda application present
      true
      products
      1. Active Ingredient
        ZENOCUTUZUMAB-ZBCO
        Appl No
        761352
        Drug Name
        BIZENGRI
        Form
        INJECTION;SOLUTION
        Product No
        001
        Reference Drug
        0
        Reference Standard
        0
        Strength
        375MG/18.75ML
        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. BLA761352
    brand names
    1. BIZENGRI
    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
    514
    end exclusive
    true
    exact text
    1 INDICATIONS AND USAGE BIZENGRI® is a bispecific HER2- and HER3-directed antibody indicated for the treatment of: Adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.1 ) Adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.2 ) Adults w
    label id
    777005ee-d019-4976-abb4-b998cf68e05f
    offset unit
    unicode_code_points
    source array index
    0
    source field
    indications_and_usage_exact
    source text sha256
    c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
    start
    0
    current approval status
    not_reconciled
    duplicate text group
    dup-ec8f871d9065eb8e1efb
    extraction review status
    automated_candidate_pending_source_review
    generic names
    1. ZENOCUTUZUMAB
    id
    ind-span-9f2eeb5dc2c28c553beb
    label id
    777005ee-d019-4976-abb4-b998cf68e05f
    positive predicate support span
    end
    92
    end exclusive
    true
    exact text
    is a bispecific HER2- and HER3-directed antibody indicated
    label id
    777005ee-d019-4976-abb4-b998cf68e05f
    offset unit
    unicode_code_points
    source array index
    0
    source field
    indications_and_usage_exact
    source text sha256
    c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
    start
    34
    qualifier mentions
    1. context exact
      and HER3-directed antibody indicated for the treatment of: Adults with advanced, unresectable or metastatic non-small cell lu
      kind
      age
      polarity
      not_inferred
      span
      end
      121
      end exclusive
      true
      exact text
      Adults
      label id
      777005ee-d019-4976-abb4-b998cf68e05f
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
      start
      115
    2. context exact
      1 INDICATIONS AND USAGE BIZENGRI® is a bispecific HER2- and HER3-directed antibody indicated for the treatment of: Adults with advanced, unresectable or m
      kind
      biomarker
      polarity
      not_inferred
      span
      end
      94
      end exclusive
      true
      exact text
      HER2- and HER3-directed antibody indicated f
      label id
      777005ee-d019-4976-abb4-b998cf68e05f
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
      start
      50
    3. context exact
      for the treatment of: Adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 ( NRG1 ) gene fusion with diseas
      kind
      biomarker
      polarity
      not_inferred
      span
      end
      196
      end exclusive
      true
      exact text
      metastatic non-small cell lung cancer (NSCL
      label id
      777005ee-d019-4976-abb4-b998cf68e05f
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
      start
      153
    4. context exact
      rected antibody indicated for the treatment of: Adults with advanced, unresectable or metastatic non-small cell lung cancer (NSC
      kind
      stage_or_setting
      polarity
      not_inferred
      span
      end
      135
      end exclusive
      true
      exact text
      advanced
      label id
      777005ee-d019-4976-abb4-b998cf68e05f
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
      start
      127
    5. context exact
      ibody indicated for the treatment of: Adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 ( NRG1 ) gene fusion
      kind
      stage_or_setting
      polarity
      not_inferred
      span
      end
      184
      end exclusive
      true
      exact text
      unresectable or metastatic non-small cell lung
      label id
      777005ee-d019-4976-abb4-b998cf68e05f
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
      start
      137
    6. context exact
      1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.1 )
      kind
      prior_therapy_or_line
      polarity
      not_inferred
      span
      end
      304
      end exclusive
      true
      exact text
      prior systemic therapy
      label id
      777005ee-d019-4976-abb4-b998cf68e05f
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
      start
      282
    regulatory links
      schema version
      0.1.0
      source batch sha256
      a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
      source defined aliases
      1. abbreviation
        NSCLC
        definition exact
        non-small cell lung cancer
        definition span
        end
        198
        end exclusive
        true
        exact text
        non-small cell lung cancer (NSCLC)
        label id
        777005ee-d019-4976-abb4-b998cf68e05f
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
        start
        164
      source span
      end
      314
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE BIZENGRI® is a bispecific HER2- and HER3-directed antibody indicated for the treatment of: Adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.1 )
      label id
      777005ee-d019-4976-abb4-b998cf68e05f
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
      start
      0
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%22777005ee-d019-4976-abb4-b998cf68e05f%22
      spl effective date
      2026-05-19
      spl set id
      203daea4-fc87-40a4-a92f-ba2351b16de1
      spl version
      3
      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. BLA761352
      brand names
      1. BIZENGRI
      classification reasons
      1. inherited_predicate_from_same_label_section_requires_review
      2. no_tumor_directed_keyword_in_positive_statement
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      705
      end exclusive
      true
      exact text
      Adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.1 ) Adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.2 ) Adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy. ( 1.3 ) *This indication
      label id
      777005ee-d019-4976-abb4-b998cf68e05f
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
      start
      115
      current approval status
      not_reconciled
      duplicate text group
      dup-31277863226ef3b0228f
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. ZENOCUTUZUMAB
      id
      ind-span-ac3253393977c87eb8b6
      label id
      777005ee-d019-4976-abb4-b998cf68e05f
      positive predicate support span
      end
      92
      end exclusive
      true
      exact text
      is a bispecific HER2- and HER3-directed antibody indicated
      label id
      777005ee-d019-4976-abb4-b998cf68e05f
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
      start
      34
      qualifier mentions
      1. context exact
        Adults with advanced, unresectable or metastatic pancreatic adenoc
        kind
        age
        polarity
        not_inferred
        span
        end
        321
        end exclusive
        true
        exact text
        Adults
        label id
        777005ee-d019-4976-abb4-b998cf68e05f
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
        start
        315
      2. context exact
        Adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progres
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        396
        end exclusive
        true
        exact text
        metastatic pancreatic adenocarcinoma harbor
        label id
        777005ee-d019-4976-abb4-b998cf68e05f
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
        start
        353
      3. context exact
        Adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harbo
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        335
        end exclusive
        true
        exact text
        advanced
        label id
        777005ee-d019-4976-abb4-b998cf68e05f
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
        start
        327
      4. context exact
        Adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with dis
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        384
        end exclusive
        true
        exact text
        unresectable or metastatic pancreatic adenocarc
        label id
        777005ee-d019-4976-abb4-b998cf68e05f
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
        start
        337
      5. context exact
        1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.2 )
        kind
        prior_therapy_or_line
        polarity
        not_inferred
        span
        end
        495
        end exclusive
        true
        exact text
        prior systemic therapy
        label id
        777005ee-d019-4976-abb4-b998cf68e05f
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
        start
        473
      regulatory links
        schema version
        0.1.0
        source batch sha256
        a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
        source defined aliases
        1. abbreviation
          NSCLC
          definition exact
          non-small cell lung cancer
          definition span
          end
          198
          end exclusive
          true
          exact text
          non-small cell lung cancer (NSCLC)
          label id
          777005ee-d019-4976-abb4-b998cf68e05f
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
          start
          164
        source span
        end
        505
        end exclusive
        true
        exact text
        Adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.2 )
        label id
        777005ee-d019-4976-abb4-b998cf68e05f
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
        start
        315
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22777005ee-d019-4976-abb4-b998cf68e05f%22
        spl effective date
        2026-05-19
        spl set id
        203daea4-fc87-40a4-a92f-ba2351b16de1
        spl version
        3
        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
        non_oncology_or_unclear_candidate
        Passage 3 · positive indication candidate
        application numbers
        1. BLA761352
        brand names
        1. BIZENGRI
        classification reasons
        1. inherited_predicate_from_same_label_section_requires_review
        2. no_tumor_directed_keyword_in_positive_statement
        clinical review status
        pending
        content role
        positive_indication_candidate
        context span
        end
        880
        end exclusive
        true
        exact text
        ( 1.1 ) Adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.2 ) Adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy. ( 1.3 ) *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
        label id
        777005ee-d019-4976-abb4-b998cf68e05f
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
        start
        306
        current approval status
        not_reconciled
        duplicate text group
        dup-4bd524876a44c18c7c4d
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. ZENOCUTUZUMAB
        id
        ind-span-199b3d0dca351a17d1f2
        label id
        777005ee-d019-4976-abb4-b998cf68e05f
        positive predicate support span
        end
        92
        end exclusive
        true
        exact text
        is a bispecific HER2- and HER3-directed antibody indicated
        label id
        777005ee-d019-4976-abb4-b998cf68e05f
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
        start
        34
        qualifier mentions
        1. context exact
          Adults with advanced, unresectable or metastatic cholangiocarcinom
          kind
          age
          polarity
          not_inferred
          span
          end
          512
          end exclusive
          true
          exact text
          Adults
          label id
          777005ee-d019-4976-abb4-b998cf68e05f
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
          start
          506
        2. context exact
          Adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          587
          end exclusive
          true
          exact text
          metastatic cholangiocarcinoma harboring a n
          label id
          777005ee-d019-4976-abb4-b998cf68e05f
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
          start
          544
        3. context exact
          Adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a
          kind
          stage_or_setting
          polarity
          not_inferred
          span
          end
          526
          end exclusive
          true
          exact text
          advanced
          label id
          777005ee-d019-4976-abb4-b998cf68e05f
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
          start
          518
        4. context exact
          Adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease pr
          kind
          stage_or_setting
          polarity
          not_inferred
          span
          end
          575
          end exclusive
          true
          exact text
          unresectable or metastatic cholangiocarcinoma h
          label id
          777005ee-d019-4976-abb4-b998cf68e05f
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
          start
          528
        5. context exact
          1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.
          kind
          prior_therapy_or_line
          polarity
          not_inferred
          span
          end
          679
          end exclusive
          true
          exact text
          prior systemic therapy
          label id
          777005ee-d019-4976-abb4-b998cf68e05f
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
          start
          657
        regulatory links
          schema version
          0.1.0
          source batch sha256
          a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
          source defined aliases
          1. abbreviation
            NSCLC
            definition exact
            non-small cell lung cancer
            definition span
            end
            198
            end exclusive
            true
            exact text
            non-small cell lung cancer (NSCLC)
            label id
            777005ee-d019-4976-abb4-b998cf68e05f
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
            start
            164
          source span
          end
          680
          end exclusive
          true
          exact text
          Adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.
          label id
          777005ee-d019-4976-abb4-b998cf68e05f
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
          start
          506
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%22777005ee-d019-4976-abb4-b998cf68e05f%22
          spl effective date
          2026-05-19
          spl set id
          203daea4-fc87-40a4-a92f-ba2351b16de1
          spl version
          3
          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
          non_oncology_or_unclear_candidate
          Passage 4 · approval contingency
          application numbers
          1. BLA761352
          brand names
          1. BIZENGRI
          classification reasons
          1. approval_contingency_words
          clinical review status
          pending
          content role
          approval_contingency
          context span
          end
          1001
          end exclusive
          true
          exact text
          stemic therapy.* ( 1.2 ) Adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy. ( 1.3 ) *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). 1.1 Advanced Unresectable or Metastatic NRG1 Fusion-Positive
          label id
          777005ee-d019-4976-abb4-b998cf68e05f
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
          start
          481
          current approval status
          not_reconciled
          duplicate text group
          dup-139a7b6364c71170ea3a
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. ZENOCUTUZUMAB
          id
          ind-span-2a6edf8daf8e5602f263
          label id
          777005ee-d019-4976-abb4-b998cf68e05f
          positive predicate support span
          Source null
          qualifier mentions
            regulatory links
              schema version
              0.1.0
              source batch sha256
              a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
              source defined aliases
              1. abbreviation
                NSCLC
                definition exact
                non-small cell lung cancer
                definition span
                end
                198
                end exclusive
                true
                exact text
                non-small cell lung cancer (NSCLC)
                label id
                777005ee-d019-4976-abb4-b998cf68e05f
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                start
                164
              source span
              end
              801
              end exclusive
              true
              exact text
              ( 1.3 ) *This indication is approved under accelerated approval based on overall response rate and duration of response.
              label id
              777005ee-d019-4976-abb4-b998cf68e05f
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
              start
              681
              source url
              https://api.fda.gov/drug/label.json?search=id%3A%22777005ee-d019-4976-abb4-b998cf68e05f%22
              spl effective date
              2026-05-19
              spl set id
              203daea4-fc87-40a4-a92f-ba2351b16de1
              spl version
              3
              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
              not_applicable
              Passage 5 · approval contingency
              application numbers
              1. BLA761352
              brand names
              1. BIZENGRI
              classification reasons
              1. approval_contingency_words
              clinical review status
              pending
              content role
              approval_contingency
              context span
              end
              1140
              end exclusive
              true
              exact text
              RG1 ) gene fusion with disease progression on or after prior systemic therapy. ( 1.3 ) *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). 1.1 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Non-Small Cell Lung Cancer BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic non-small cell lung
              label id
              777005ee-d019-4976-abb4-b998cf68e05f
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
              start
              602
              current approval status
              not_reconciled
              duplicate text group
              dup-86f171d5e688d8aefb18
              extraction review status
              automated_candidate_pending_source_review
              generic names
              1. ZENOCUTUZUMAB
              id
              ind-span-96ba952d7b80f4de2979
              label id
              777005ee-d019-4976-abb4-b998cf68e05f
              positive predicate support span
              Source null
              qualifier mentions
                regulatory links
                  schema version
                  0.1.0
                  source batch sha256
                  a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                  source defined aliases
                  1. abbreviation
                    NSCLC
                    definition exact
                    non-small cell lung cancer
                    definition span
                    end
                    198
                    end exclusive
                    true
                    exact text
                    non-small cell lung cancer (NSCLC)
                    label id
                    777005ee-d019-4976-abb4-b998cf68e05f
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                    start
                    164
                  source span
                  end
                  940
                  end exclusive
                  true
                  exact text
                  Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
                  label id
                  777005ee-d019-4976-abb4-b998cf68e05f
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                  start
                  802
                  source url
                  https://api.fda.gov/drug/label.json?search=id%3A%22777005ee-d019-4976-abb4-b998cf68e05f%22
                  spl effective date
                  2026-05-19
                  spl set id
                  203daea4-fc87-40a4-a92f-ba2351b16de1
                  spl version
                  3
                  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
                  not_applicable
                  Passage 6 · positive indication candidate
                  application numbers
                  1. BLA761352
                  brand names
                  1. BIZENGRI
                  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
                  1461
                  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). 1.1 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Non-Small Cell Lung Cancer BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1) ]. Continued approval for this indication may be contingent
                  label id
                  777005ee-d019-4976-abb4-b998cf68e05f
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                  start
                  741
                  current approval status
                  not_reconciled
                  duplicate text group
                  dup-2daf0cb045e87f81ec71
                  extraction review status
                  automated_candidate_pending_source_review
                  generic names
                  1. ZENOCUTUZUMAB
                  id
                  ind-span-94a5f39c015533d8807b
                  label id
                  777005ee-d019-4976-abb4-b998cf68e05f
                  positive predicate support span
                  end
                  1050
                  end exclusive
                  true
                  exact text
                  is indicated
                  label id
                  777005ee-d019-4976-abb4-b998cf68e05f
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                  start
                  1038
                  qualifier mentions
                  1. context exact
                    Cell Lung Cancer BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic non-small cell lun
                    kind
                    age
                    polarity
                    not_inferred
                    span
                    end
                    1078
                    end exclusive
                    true
                    exact text
                    adults
                    label id
                    777005ee-d019-4976-abb4-b998cf68e05f
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                    start
                    1072
                  2. context exact
                    1.1 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Non-Small Cell Lung Cancer BIZENGRI is indicated for the treatment of a
                    kind
                    biomarker
                    polarity
                    not_inferred
                    span
                    end
                    1013
                    end exclusive
                    true
                    exact text
                    Metastatic NRG1 Fusion-Positive Non-Small C
                    label id
                    777005ee-d019-4976-abb4-b998cf68e05f
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                    start
                    970
                  3. context exact
                    d for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 ( NRG1 ) gene fusion with diseas
                    kind
                    biomarker
                    polarity
                    not_inferred
                    span
                    end
                    1152
                    end exclusive
                    true
                    exact text
                    metastatic non-small cell lung cancer (NSCL
                    label id
                    777005ee-d019-4976-abb4-b998cf68e05f
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                    start
                    1109
                  4. context exact
                    1.1 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Non-Small Cell Lung Cancer BIZENGRI is indicat
                    kind
                    stage_or_setting
                    polarity
                    not_inferred
                    span
                    end
                    988
                    end exclusive
                    true
                    exact text
                    Advanced Unresectable or Metastatic NRG1 Fu
                    label id
                    777005ee-d019-4976-abb4-b998cf68e05f
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                    start
                    945
                  5. context exact
                    ncer BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 ( NRG1
                    kind
                    stage_or_setting
                    polarity
                    not_inferred
                    span
                    end
                    1127
                    end exclusive
                    true
                    exact text
                    advanced unresectable or metastatic non-sma
                    label id
                    777005ee-d019-4976-abb4-b998cf68e05f
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                    start
                    1084
                  6. context exact
                    1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.
                    kind
                    prior_therapy_or_line
                    polarity
                    not_inferred
                    span
                    end
                    1260
                    end exclusive
                    true
                    exact text
                    prior systemic therapy
                    label id
                    777005ee-d019-4976-abb4-b998cf68e05f
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                    start
                    1238
                  regulatory links
                    schema version
                    0.1.0
                    source batch sha256
                    a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                    source defined aliases
                    1. abbreviation
                      NSCLC
                      definition exact
                      non-small cell lung cancer
                      definition span
                      end
                      198
                      end exclusive
                      true
                      exact text
                      non-small cell lung cancer (NSCLC)
                      label id
                      777005ee-d019-4976-abb4-b998cf68e05f
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                      start
                      164
                    source span
                    end
                    1261
                    end exclusive
                    true
                    exact text
                    1.1 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Non-Small Cell Lung Cancer BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.
                    label id
                    777005ee-d019-4976-abb4-b998cf68e05f
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                    start
                    941
                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%22777005ee-d019-4976-abb4-b998cf68e05f%22
                    spl effective date
                    2026-05-19
                    spl set id
                    203daea4-fc87-40a4-a92f-ba2351b16de1
                    spl version
                    3
                    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 7 · approval contingency
                    application numbers
                    1. BLA761352
                    brand names
                    1. BIZENGRI
                    classification reasons
                    1. approval_contingency_words
                    clinical review status
                    pending
                    content role
                    approval_contingency
                    context span
                    end
                    1604
                    end exclusive
                    true
                    exact text
                    atment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.2 Advanced Unresectable or Metastatic NRG1 Fusion-Positive
                    label id
                    777005ee-d019-4976-abb4-b998cf68e05f
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                    start
                    1062
                    current approval status
                    not_reconciled
                    duplicate text group
                    dup-0691a6c5d8c50e778c23
                    extraction review status
                    automated_candidate_pending_source_review
                    generic names
                    1. ZENOCUTUZUMAB
                    id
                    ind-span-0ef1a837666241114bf6
                    label id
                    777005ee-d019-4976-abb4-b998cf68e05f
                    positive predicate support span
                    Source null
                    qualifier mentions
                      regulatory links
                        schema version
                        0.1.0
                        source batch sha256
                        a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                        source defined aliases
                        1. abbreviation
                          NSCLC
                          definition exact
                          non-small cell lung cancer
                          definition span
                          end
                          198
                          end exclusive
                          true
                          exact text
                          non-small cell lung cancer (NSCLC)
                          label id
                          777005ee-d019-4976-abb4-b998cf68e05f
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                          start
                          164
                        source span
                        end
                        1404
                        end exclusive
                        true
                        exact text
                        This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1) ].
                        label id
                        777005ee-d019-4976-abb4-b998cf68e05f
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                        start
                        1262
                        source url
                        https://api.fda.gov/drug/label.json?search=id%3A%22777005ee-d019-4976-abb4-b998cf68e05f%22
                        spl effective date
                        2026-05-19
                        spl set id
                        203daea4-fc87-40a4-a92f-ba2351b16de1
                        spl version
                        3
                        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
                        not_applicable
                        Passage 8 · approval contingency
                        application numbers
                        1. BLA761352
                        brand names
                        1. BIZENGRI
                        classification reasons
                        1. approval_contingency_words
                        clinical review status
                        pending
                        content role
                        approval_contingency
                        context span
                        end
                        1743
                        end exclusive
                        true
                        exact text
                        disease progression on or after prior systemic therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.2 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Pancreatic Adenocarcinoma BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic pancreatic adenocarci
                        label id
                        777005ee-d019-4976-abb4-b998cf68e05f
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                        start
                        1205
                        current approval status
                        not_reconciled
                        duplicate text group
                        dup-86f171d5e688d8aefb18
                        extraction review status
                        automated_candidate_pending_source_review
                        generic names
                        1. ZENOCUTUZUMAB
                        id
                        ind-span-404ad17693d328a6808b
                        label id
                        777005ee-d019-4976-abb4-b998cf68e05f
                        positive predicate support span
                        Source null
                        qualifier mentions
                          regulatory links
                            schema version
                            0.1.0
                            source batch sha256
                            a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                            source defined aliases
                            1. abbreviation
                              NSCLC
                              definition exact
                              non-small cell lung cancer
                              definition span
                              end
                              198
                              end exclusive
                              true
                              exact text
                              non-small cell lung cancer (NSCLC)
                              label id
                              777005ee-d019-4976-abb4-b998cf68e05f
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                              start
                              164
                            source span
                            end
                            1543
                            end exclusive
                            true
                            exact text
                            Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
                            label id
                            777005ee-d019-4976-abb4-b998cf68e05f
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                            start
                            1405
                            source url
                            https://api.fda.gov/drug/label.json?search=id%3A%22777005ee-d019-4976-abb4-b998cf68e05f%22
                            spl effective date
                            2026-05-19
                            spl set id
                            203daea4-fc87-40a4-a92f-ba2351b16de1
                            spl version
                            3
                            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
                            not_applicable
                            Passage 9 · positive indication candidate
                            application numbers
                            1. BLA761352
                            brand names
                            1. BIZENGRI
                            classification reasons
                            1. explicit_positive_indication_predicate
                            2. no_tumor_directed_keyword_in_positive_statement
                            clinical review status
                            pending
                            content role
                            positive_indication_candidate
                            context span
                            end
                            2054
                            end exclusive
                            true
                            exact text
                            ate and duration of response [see Clinical Studies (14.1) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.2 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Pancreatic Adenocarcinoma BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingen
                            label id
                            777005ee-d019-4976-abb4-b998cf68e05f
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                            start
                            1344
                            current approval status
                            not_reconciled
                            duplicate text group
                            dup-3c5939c6800358bacc1d
                            extraction review status
                            automated_candidate_pending_source_review
                            generic names
                            1. ZENOCUTUZUMAB
                            id
                            ind-span-0adc6738aed4e1ab44e9
                            label id
                            777005ee-d019-4976-abb4-b998cf68e05f
                            positive predicate support span
                            end
                            1652
                            end exclusive
                            true
                            exact text
                            is indicated
                            label id
                            777005ee-d019-4976-abb4-b998cf68e05f
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                            start
                            1640
                            qualifier mentions
                            1. context exact
                              c Adenocarcinoma BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic pancreatic adenoca
                              kind
                              age
                              polarity
                              not_inferred
                              span
                              end
                              1680
                              end exclusive
                              true
                              exact text
                              adults
                              label id
                              777005ee-d019-4976-abb4-b998cf68e05f
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                              start
                              1674
                            2. context exact
                              1.2 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Pancreatic Adenocarcinoma BIZENGRI is indicated for the treatment of ad
                              kind
                              biomarker
                              polarity
                              not_inferred
                              span
                              end
                              1616
                              end exclusive
                              true
                              exact text
                              Metastatic NRG1 Fusion-Positive Pancreatic
                              label id
                              777005ee-d019-4976-abb4-b998cf68e05f
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                              start
                              1573
                            3. context exact
                              d for the treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progres
                              kind
                              biomarker
                              polarity
                              not_inferred
                              span
                              end
                              1754
                              end exclusive
                              true
                              exact text
                              metastatic pancreatic adenocarcinoma harbor
                              label id
                              777005ee-d019-4976-abb4-b998cf68e05f
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                              start
                              1711
                            4. context exact
                              1.2 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Pancreatic Adenocarcinoma BIZENGRI is indicate
                              kind
                              stage_or_setting
                              polarity
                              not_inferred
                              span
                              end
                              1591
                              end exclusive
                              true
                              exact text
                              Advanced Unresectable or Metastatic NRG1 Fu
                              label id
                              777005ee-d019-4976-abb4-b998cf68e05f
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                              start
                              1548
                            5. context exact
                              noma BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fu
                              kind
                              stage_or_setting
                              polarity
                              not_inferred
                              span
                              end
                              1729
                              end exclusive
                              true
                              exact text
                              advanced unresectable or metastatic pancrea
                              label id
                              777005ee-d019-4976-abb4-b998cf68e05f
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                              start
                              1686
                            6. context exact
                              1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.
                              kind
                              prior_therapy_or_line
                              polarity
                              not_inferred
                              span
                              end
                              1853
                              end exclusive
                              true
                              exact text
                              prior systemic therapy
                              label id
                              777005ee-d019-4976-abb4-b998cf68e05f
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                              start
                              1831
                            regulatory links
                            1. candidate source span
                              end
                              1854
                              end exclusive
                              true
                              exact text
                              1.2 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Pancreatic Adenocarcinoma BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.
                              label id
                              777005ee-d019-4976-abb4-b998cf68e05f
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                              start
                              1544
                              fda indication exact
                              Treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.
                              fda source row index
                              16
                              fda source sha256
                              8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
                              fda status record id
                              fda-aa-fb71fba1f2fb5f1e6b1a
                              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
                              2024-12-04
                              supporting anchor spans
                              schema version
                              0.1.0
                              source batch sha256
                              a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                              source defined aliases
                              1. abbreviation
                                NSCLC
                                definition exact
                                non-small cell lung cancer
                                definition span
                                end
                                198
                                end exclusive
                                true
                                exact text
                                non-small cell lung cancer (NSCLC)
                                label id
                                777005ee-d019-4976-abb4-b998cf68e05f
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                                start
                                164
                              source span
                              end
                              1854
                              end exclusive
                              true
                              exact text
                              1.2 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Pancreatic Adenocarcinoma BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.
                              label id
                              777005ee-d019-4976-abb4-b998cf68e05f
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                              start
                              1544
                              source url
                              https://api.fda.gov/drug/label.json?search=id%3A%22777005ee-d019-4976-abb4-b998cf68e05f%22
                              spl effective date
                              2026-05-19
                              spl set id
                              203daea4-fc87-40a4-a92f-ba2351b16de1
                              spl version
                              3
                              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
                              non_oncology_or_unclear_candidate

                              Read indication-specific status → · whole_fda_indication_text_present

                              Passage 10 · approval contingency
                              application numbers
                              1. BLA761352
                              brand names
                              1. BIZENGRI
                              classification reasons
                              1. approval_contingency_words
                              clinical review status
                              pending
                              content role
                              approval_contingency
                              context span
                              end
                              2198
                              end exclusive
                              true
                              exact text
                              r the treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.3 Advanced Unresectable or Metastatic NRG1 Fusion-Positive
                              label id
                              777005ee-d019-4976-abb4-b998cf68e05f
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                              start
                              1655
                              current approval status
                              not_reconciled
                              duplicate text group
                              dup-d0214dabdf857eb2b9ae
                              extraction review status
                              automated_candidate_pending_source_review
                              generic names
                              1. ZENOCUTUZUMAB
                              id
                              ind-span-34965996e8190845a796
                              label id
                              777005ee-d019-4976-abb4-b998cf68e05f
                              positive predicate support span
                              Source null
                              qualifier mentions
                                regulatory links
                                  schema version
                                  0.1.0
                                  source batch sha256
                                  a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                                  source defined aliases
                                  1. abbreviation
                                    NSCLC
                                    definition exact
                                    non-small cell lung cancer
                                    definition span
                                    end
                                    198
                                    end exclusive
                                    true
                                    exact text
                                    non-small cell lung cancer (NSCLC)
                                    label id
                                    777005ee-d019-4976-abb4-b998cf68e05f
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                                    start
                                    164
                                  source span
                                  end
                                  1998
                                  end exclusive
                                  true
                                  exact text
                                  This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.2) ] .
                                  label id
                                  777005ee-d019-4976-abb4-b998cf68e05f
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                                  start
                                  1855
                                  source url
                                  https://api.fda.gov/drug/label.json?search=id%3A%22777005ee-d019-4976-abb4-b998cf68e05f%22
                                  spl effective date
                                  2026-05-19
                                  spl set id
                                  203daea4-fc87-40a4-a92f-ba2351b16de1
                                  spl version
                                  3
                                  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
                                  not_applicable
                                  Passage 11 · approval contingency
                                  application numbers
                                  1. BLA761352
                                  brand names
                                  1. BIZENGRI
                                  classification reasons
                                  1. approval_contingency_words
                                  clinical review status
                                  pending
                                  content role
                                  approval_contingency
                                  context span
                                  end
                                  2337
                                  end exclusive
                                  true
                                  exact text
                                  disease progression on or after prior systemic therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.3 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Cholangiocarcinoma BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring
                                  label id
                                  777005ee-d019-4976-abb4-b998cf68e05f
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                                  start
                                  1799
                                  current approval status
                                  not_reconciled
                                  duplicate text group
                                  dup-86f171d5e688d8aefb18
                                  extraction review status
                                  automated_candidate_pending_source_review
                                  generic names
                                  1. ZENOCUTUZUMAB
                                  id
                                  ind-span-ca5b2b4ed8a1731d4d80
                                  label id
                                  777005ee-d019-4976-abb4-b998cf68e05f
                                  positive predicate support span
                                  Source null
                                  qualifier mentions
                                    regulatory links
                                      schema version
                                      0.1.0
                                      source batch sha256
                                      a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                                      source defined aliases
                                      1. abbreviation
                                        NSCLC
                                        definition exact
                                        non-small cell lung cancer
                                        definition span
                                        end
                                        198
                                        end exclusive
                                        true
                                        exact text
                                        non-small cell lung cancer (NSCLC)
                                        label id
                                        777005ee-d019-4976-abb4-b998cf68e05f
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                                        start
                                        164
                                      source span
                                      end
                                      2137
                                      end exclusive
                                      true
                                      exact text
                                      Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
                                      label id
                                      777005ee-d019-4976-abb4-b998cf68e05f
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                                      start
                                      1999
                                      source url
                                      https://api.fda.gov/drug/label.json?search=id%3A%22777005ee-d019-4976-abb4-b998cf68e05f%22
                                      spl effective date
                                      2026-05-19
                                      spl set id
                                      203daea4-fc87-40a4-a92f-ba2351b16de1
                                      spl version
                                      3
                                      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
                                      not_applicable
                                      Passage 12 · positive indication candidate
                                      application numbers
                                      1. BLA761352
                                      brand names
                                      1. BIZENGRI
                                      classification reasons
                                      1. explicit_positive_indication_predicate
                                      2. no_tumor_directed_keyword_in_positive_statement
                                      clinical review status
                                      pending
                                      content role
                                      positive_indication_candidate
                                      context span
                                      end
                                      2434
                                      end exclusive
                                      true
                                      exact text
                                      te and duration of response [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.3 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Cholangiocarcinoma BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.
                                      label id
                                      777005ee-d019-4976-abb4-b998cf68e05f
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                                      start
                                      1938
                                      current approval status
                                      not_reconciled
                                      duplicate text group
                                      dup-610c2da9ef3771f9c066
                                      extraction review status
                                      automated_candidate_pending_source_review
                                      generic names
                                      1. ZENOCUTUZUMAB
                                      id
                                      ind-span-a3e639774239dc12e9ec
                                      label id
                                      777005ee-d019-4976-abb4-b998cf68e05f
                                      positive predicate support span
                                      end
                                      2239
                                      end exclusive
                                      true
                                      exact text
                                      is indicated
                                      label id
                                      777005ee-d019-4976-abb4-b998cf68e05f
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                                      start
                                      2227
                                      qualifier mentions
                                      1. context exact
                                        olangiocarcinoma BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma
                                        kind
                                        age
                                        polarity
                                        not_inferred
                                        span
                                        end
                                        2267
                                        end exclusive
                                        true
                                        exact text
                                        adults
                                        label id
                                        777005ee-d019-4976-abb4-b998cf68e05f
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                                        start
                                        2261
                                      2. context exact
                                        1.3 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Cholangiocarcinoma BIZENGRI is indicated for the treatment of adults wi
                                        kind
                                        biomarker
                                        polarity
                                        not_inferred
                                        span
                                        end
                                        2210
                                        end exclusive
                                        true
                                        exact text
                                        Metastatic NRG1 Fusion-Positive Cholangioca
                                        label id
                                        777005ee-d019-4976-abb4-b998cf68e05f
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                                        start
                                        2167
                                      3. context exact
                                        d for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on
                                        kind
                                        biomarker
                                        polarity
                                        not_inferred
                                        span
                                        end
                                        2341
                                        end exclusive
                                        true
                                        exact text
                                        metastatic cholangiocarcinoma harboring a n
                                        label id
                                        777005ee-d019-4976-abb4-b998cf68e05f
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                                        start
                                        2298
                                      4. context exact
                                        1.3 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Cholangiocarcinoma BIZENGRI is indicated for t
                                        kind
                                        stage_or_setting
                                        polarity
                                        not_inferred
                                        span
                                        end
                                        2185
                                        end exclusive
                                        true
                                        exact text
                                        Advanced Unresectable or Metastatic NRG1 Fu
                                        label id
                                        777005ee-d019-4976-abb4-b998cf68e05f
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                                        start
                                        2142
                                      5. context exact
                                        noma BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion wi
                                        kind
                                        stage_or_setting
                                        polarity
                                        not_inferred
                                        span
                                        end
                                        2316
                                        end exclusive
                                        true
                                        exact text
                                        advanced unresectable or metastatic cholang
                                        label id
                                        777005ee-d019-4976-abb4-b998cf68e05f
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                                        start
                                        2273
                                      6. context exact
                                        1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.
                                        kind
                                        prior_therapy_or_line
                                        polarity
                                        not_inferred
                                        span
                                        end
                                        2433
                                        end exclusive
                                        true
                                        exact text
                                        prior systemic therapy
                                        label id
                                        777005ee-d019-4976-abb4-b998cf68e05f
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                                        start
                                        2411
                                      regulatory links
                                        schema version
                                        0.1.0
                                        source batch sha256
                                        a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                                        source defined aliases
                                        1. abbreviation
                                          NSCLC
                                          definition exact
                                          non-small cell lung cancer
                                          definition span
                                          end
                                          198
                                          end exclusive
                                          true
                                          exact text
                                          non-small cell lung cancer (NSCLC)
                                          label id
                                          777005ee-d019-4976-abb4-b998cf68e05f
                                          offset unit
                                          unicode_code_points
                                          source array index
                                          0
                                          source field
                                          indications_and_usage_exact
                                          source text sha256
                                          c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                                          start
                                          164
                                        source span
                                        end
                                        2434
                                        end exclusive
                                        true
                                        exact text
                                        1.3 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Cholangiocarcinoma BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.
                                        label id
                                        777005ee-d019-4976-abb4-b998cf68e05f
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
                                        start
                                        2138
                                        source url
                                        https://api.fda.gov/drug/label.json?search=id%3A%22777005ee-d019-4976-abb4-b998cf68e05f%22
                                        spl effective date
                                        2026-05-19
                                        spl set id
                                        203daea4-fc87-40a4-a92f-ba2351b16de1
                                        spl version
                                        3
                                        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
                                        non_oncology_or_unclear_candidate

                                        Preserved source evidence · Not medical advice