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LABELS · 0fd3e81b-38c9-4d19-b075-9256049a9d41

HERNEXEOS

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
2026-08-13
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE HERNEXEOS is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test [see Dosage and Administration (2.1) ] . This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. HERNEXEOS is a kinase inhibitor indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test. ( 1 ) This indication is approved under accelerated approval based on objective 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. ( 1 )
Full extracted label fields
application numbers
  1. NDA219042
boxed warning exact
    brand names
    1. HERNEXEOS
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3fabf12-354e-4e5c-b5de-20fdb579b783
    generic names
    1. ZONGERTINIB
    id
    0fd3e81b-38c9-4d19-b075-9256049a9d41
    indications and usage exact
    1. 1 INDICATIONS AND USAGE HERNEXEOS is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test [see Dosage and Administration (2.1) ] . This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. HERNEXEOS is a kinase inhibitor indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test. ( 1 ) This indication is approved under accelerated approval based on objective 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. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Boehringer Ingelheim Pharmaceuticals, Inc.
      matched search terms
      1. cancer
      2. tumors
      package ndcs
      1. 0597-9257-86
      2. 0597-9257-59
      product ndcs
      1. 0597-9257
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Indications and Usage ( 1 ) 2/2026 Dosage and Administration ( 2.1 ) 7/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 2721609
      2. 2721615
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00000.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
      0
      total
      830
      sha256
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      url
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      source url
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      spl effective date
      2026-08-13
      spl effective time
      20260813
      spl set id
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      spl version
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      substance names
      1. ZONGERTINIB
      uniis
      1. DRH7R67UVL
      verification flags
      1. oncology_keyword_candidate_not_clinically_classified
      2. spl_text_not_verified_identical_to_latest_approved_label
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      Drugs@FDA application source records
      1. application number
        NDA219042
        payload
        all indexed label documents
        1. Appl No
          219042
          Application Docs Date
          2025-08-11 00:00:00
          Application Docs ID
          83070
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          219042
          Application Docs Date
          2026-03-02 00:00:00
          Application Docs ID
          85197
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        3. Appl No
          219042
          Application Docs Date
          2026-08-04 00:00:00
          Application Docs ID
          86805
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        4. Appl No
          219042
          Application Docs Date
          2026-08-04 00:00:00
          Application Docs ID
          86806
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          219042
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2025-08-08 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          219042
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2026-02-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          219042
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          2026-07-31 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          219042
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2026-07-31 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA219042
        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
        2026-07-31
        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
          219042
          Application Docs Date
          2026-08-04 00:00:00
          Application Docs ID
          86805
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
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        2. Appl No
          219042
          Application Docs Date
          2026-08-04 00:00:00
          Application Docs ID
          86806
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        official application record
        Appl No
        219042
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        BOEHRINGER INGELHEIM
        openfda application present
        true
        products
        1. Active Ingredient
          ZONGERTINIB
          Appl No
          219042
          Drug Name
          HERNEXEOS
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          60MG
          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. NDA219042
      brand names
      1. HERNEXEOS
      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
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      517
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE HERNEXEOS is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test [see Dosage and Administration (2.1) ] . This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingen
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      is indicated
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      qualifier mentions
      1. context exact
        TIONS AND USAGE HERNEXEOS is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell
        kind
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        adult patients
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      2. context exact
        ed for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kina
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        metastatic non-squamous non-small cell lung
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      3. context exact
        uamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test [see Dos
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        exact text
        HER2 (ERBB2) tyrosine kinase domain activati
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      4. context exact
        EXEOS is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) t
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        stage_or_setting
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        not_inferred
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        end exclusive
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        exact text
        unresectable or metastatic non-squamous non-sma
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      regulatory links
      1. candidate source span
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        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE HERNEXEOS is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test [see Dosage and Administration (2.1) ] .
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        fda indication exact
        Treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test
        fda source row index
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        fda source sha256
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          non-small cell lung cancer (NSCLC)
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        1 INDICATIONS AND USAGE HERNEXEOS is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test [see Dosage and Administration (2.1) ] .
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        Source null
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        Source null
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        Source null
        line
        Source null
        prior therapy
        Source null
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        Source null
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        Source null
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        Read indication-specific status → · whole_fda_indication_text_present

        Passage 2 · approval contingency
        application numbers
        1. NDA219042
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        -squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test [see Dosage and Administration (2.1) ] . This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. HERNEXEOS is a kinase inhibitor indicated for the treatment of
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            This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14) ] .
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            uthorized test [see Dosage and Administration (2.1) ] . This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. HERNEXEOS is a kinase inhibitor indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine k
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