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LABELS · 3a365319-7ba8-4454-8239-7b0e7ff8a18e

Gilotrif

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2025-11-13
Captured
2026-09-09T23:37:44.904352+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE GILOTRIF is a kinase inhibitor indicated for: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test ( 1.1 ) Limitations of Use : Safety and efficacy of GILOTRIF were not established in patients whose tumors have resistant EGFR mutations ( 1.1 ) Treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy ( 1.2 ) 1.1 EGFR Mutation-Positive, Metastatic Non-Small Cell Lung Cancer GILOTRIF is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test [see Dosage and Administration (2.1) , Clinical Pharmacology (12.1) , Clinical Studies (14.1) ]. Limitations of Use : The safety and efficacy of GILOTRIF have not been established in patients whose tumors have resistant EGFR mutations [see Clinical Studies (14.1) ]. 1.2 Previously Treated, Metastatic Squamous NSCLC GILOTRIF is indicated for the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy .
Full extracted label fields
application numbers
  1. NDA201292
boxed warning exact
    brand names
    1. Gilotrif
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fd638e5e-8032-e7ca-0179-95e96ab5d387
    generic names
    1. AFATINIB
    id
    3a365319-7ba8-4454-8239-7b0e7ff8a18e
    indications and usage exact
    1. 1 INDICATIONS AND USAGE GILOTRIF is a kinase inhibitor indicated for: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test ( 1.1 ) Limitations of Use : Safety and efficacy of GILOTRIF were not established in patients whose tumors have resistant EGFR mutations ( 1.1 ) Treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy ( 1.2 ) 1.1 EGFR Mutation-Positive, Metastatic Non-Small Cell Lung Cancer GILOTRIF is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test [see Dosage and Administration (2.1) , Clinical Pharmacology (12.1) , Clinical Studies (14.1) ]. Limitations of Use : The safety and efficacy of GILOTRIF have not been established in patients whose tumors have resistant EGFR mutations [see Clinical Studies (14.1) ]. 1.2 Previously Treated, Metastatic Squamous NSCLC GILOTRIF is indicated for the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy .
    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. 0597-0141-30
      2. 0597-0137-30
      3. 0597-0137-90
      4. 0597-0138-30
      5. 0597-0138-95
      product ndcs
      1. 0597-0137
      2. 0597-0141
      3. 0597-0138
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 1430446
        2. 1430449
        3. 1430451
        4. 1430453
        5. 1430455
        6. 1430457
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00200.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
        200
        total
        830
        sha256
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        url
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        source url
        https://api.fda.gov/drug/label.json?search=id%3A%223a365319-7ba8-4454-8239-7b0e7ff8a18e%22
        spl effective date
        2025-11-13
        spl effective time
        20251113
        spl set id
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        spl version
        20
        substance names
        1. AFATINIB
        uniis
        1. 41UD74L59M
        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
          NDA201292
          payload
          all indexed label documents
          1. Appl No
            201292
            Application Docs Date
            2013-07-12 00:00:00
            Application Docs ID
            19009
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            201292
            Application Docs Date
            2015-11-12 00:00:00
            Application Docs ID
            19010
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            6
            Submission Type
            SUPPL
          3. Appl No
            201292
            Application Docs Date
            2016-04-19 00:00:00
            Application Docs ID
            19011
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            7
            Submission Type
            SUPPL
          4. Appl No
            201292
            Application Docs Date
            2015-12-31 00:00:00
            Application Docs ID
            19012
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            8
            Submission Type
            SUPPL
          5. Appl No
            201292
            Application Docs Date
            2016-04-27 00:00:00
            Application Docs ID
            19013
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          6. Appl No
            201292
            Application Docs Date
            2013-07-30 00:00:00
            Application Docs ID
            40064
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            SUPPL
          7. Appl No
            201292
            Application Docs Date
            2013-11-22 00:00:00
            Application Docs ID
            40065
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            SUPPL
          8. Appl No
            201292
            Application Docs Date
            2016-10-06 00:00:00
            Application Docs ID
            45498
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            10
            Submission Type
            SUPPL
          9. Appl No
            201292
            Application Docs Date
            2017-11-07 00:00:00
            Application Docs ID
            50323
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            12
            Submission Type
            SUPPL
          10. Appl No
            201292
            Application Docs Date
            2018-01-12 00:00:00
            Application Docs ID
            51049
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            14
            Submission Type
            SUPPL
          11. Appl No
            201292
            Application Docs Date
            2019-10-15 00:00:00
            Application Docs ID
            60551
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            15
            Submission Type
            SUPPL
          12. Appl No
            201292
            Application Docs Date
            2022-04-11 00:00:00
            Application Docs ID
            70746
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            17
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            201292
            Review Priority
            PRIORITY
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2013-07-12 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            201292
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2013-07-23 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            201292
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2013-11-21 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            201292
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            3
            Submission Status
            AP
            Submission Status Date
            2014-07-31 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            201292
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            6
            Submission Status
            AP
            Submission Status Date
            2015-11-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            201292
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            7
            Submission Status
            AP
            Submission Status Date
            2016-04-15 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            201292
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            8
            Submission Status
            AP
            Submission Status Date
            2015-12-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            201292
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            9
            Submission Status
            AP
            Submission Status Date
            2016-04-20 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            201292
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            10
            Submission Status
            AP
            Submission Status Date
            2016-10-04 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            201292
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            12
            Submission Status
            AP
            Submission Status Date
            2017-11-06 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            201292
            Review Priority
            PRIORITY
            Submission Class Code ID
            2
            Submission No
            14
            Submission Status
            AP
            Submission Status Date
            2018-01-12 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            201292
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            15
            Submission Status
            AP
            Submission Status Date
            2019-10-11 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA201292
          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
          2022-04-07
          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
            201292
            Application Docs Date
            2022-04-11 00:00:00
            Application Docs ID
            70746
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            17
            Submission Type
            SUPPL
          official application record
          Appl No
          201292
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          BOEHRINGER INGELHEIM
          openfda application present
          true
          products
          1. Active Ingredient
            AFATINIB DIMALEATE
            Appl No
            201292
            Drug Name
            GILOTRIF
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            EQ 20MG BASE
            marketing status
            1. Prescription
          2. Active Ingredient
            AFATINIB DIMALEATE
            Appl No
            201292
            Drug Name
            GILOTRIF
            Form
            TABLET;ORAL
            Product No
            002
            Reference Drug
            1
            Reference Standard
            0
            Strength
            EQ 30MG BASE
            marketing status
            1. Prescription
          3. Active Ingredient
            AFATINIB DIMALEATE
            Appl No
            201292
            Drug Name
            GILOTRIF
            Form
            TABLET;ORAL
            Product No
            003
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 40MG BASE
            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. NDA201292
        brand names
        1. Gilotrif
        classification reasons
        1. explicit_positive_indication_predicate
        2. tumor_or_malignant_hematology_words_in_positive_statement
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        clinical review status
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        content role
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        context span
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        true
        exact text
        1 INDICATIONS AND USAGE GILOTRIF is a kinase inhibitor indicated for: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test ( 1.1 ) Limitations of Use : Safety and efficacy of GILOTRIF were not established in patients whose tumors have resistant EGFR mutations ( 1.1 ) Treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy ( 1.2 ) 1.1 EGFR Mutation-Positive, Metastatic Non-Small Cell Lung Cancer GILOTRIF is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have n
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        1. AFATINIB
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        1. context exact
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          kind
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        7. context exact
          ONS AND USAGE GILOTRIF is a kinase inhibitor indicated for: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test ( 1.1 ) Limitations of Use :
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          First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as d
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            definition exact
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          1 INDICATIONS AND USAGE GILOTRIF is a kinase inhibitor indicated for: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test ( 1.1 ) Limitations of Use : Safety and efficacy of GILOTRIF were not established in patients whose tumors have resistant EGFR mutations ( 1.1 ) Treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy ( 1.2 )
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