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LABELS · 940eccaf-92b4-4562-8579-24a53c1bc48d

TYKERB

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
2026-01-27
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: HEPATOTOXICITY Hepatotoxicity has been observed in clinical trials and postmarketing experience. The hepatotoxicity may be severe and deaths have been reported. Causality of the deaths is uncertain [see Warnings and Precautions (5.2)] . WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepatotoxicity has been observed in clinical trials and postmarketing experience. The hepatotoxicity may be severe and deaths have been reported. Causality of the deaths is uncertain. ( 5.2 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE TYKERB ® is indicated in combination with: capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use : Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine. letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer. TYKERB is a kinase inhibitor indicated in combination with: ( 1 ) capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use : Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine. letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.
Full extracted label fields
application numbers
  1. NDA022059
boxed warning exact
  1. WARNING: HEPATOTOXICITY Hepatotoxicity has been observed in clinical trials and postmarketing experience. The hepatotoxicity may be severe and deaths have been reported. Causality of the deaths is uncertain [see Warnings and Precautions (5.2)] . WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepatotoxicity has been observed in clinical trials and postmarketing experience. The hepatotoxicity may be severe and deaths have been reported. Causality of the deaths is uncertain. ( 5.2 )
brand names
  1. TYKERB
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eee37f88-ec6a-4c30-b8aa-e2c71f93088c
generic names
  1. LAPATINIB
id
940eccaf-92b4-4562-8579-24a53c1bc48d
indications and usage exact
  1. 1 INDICATIONS AND USAGE TYKERB ® is indicated in combination with: capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use : Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine. letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer. TYKERB is a kinase inhibitor indicated in combination with: ( 1 ) capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use : Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine. letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Novartis Pharmaceuticals Corporation
    matched search terms
    1. cancer
    2. tumors
    package ndcs
    1. 0078-0671-19
    product ndcs
    1. 0078-0671
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
      record type
      complete_spl_indications_section_candidate
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      1. ORAL
      rxcuis
      1. 672149
      2. 672152
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00500.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
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      skip
      500
      total
      830
      sha256
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      url
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      source url
      https://api.fda.gov/drug/label.json?search=id%3A%22940eccaf-92b4-4562-8579-24a53c1bc48d%22
      spl effective date
      2026-01-27
      spl effective time
      20260127
      spl set id
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      spl version
      14
      substance names
      1. LAPATINIB DITOSYLATE
      uniis
      1. G873GX646R
      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
        NDA022059
        payload
        all indexed label documents
        1. Appl No
          022059
          Application Docs Date
          2007-05-01 00:00:00
          Application Docs ID
          16861
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        2. Appl No
          022059
          Application Docs Date
          2010-02-01 00:00:00
          Application Docs ID
          16862
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        3. Appl No
          022059
          Application Docs Date
          2008-07-09 00:00:00
          Application Docs ID
          16863
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        4. Appl No
          022059
          Application Docs Date
          2010-02-01 00:00:00
          Application Docs ID
          16864
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          7
          Submission Type
          SUPPL
        5. Appl No
          022059
          Application Docs Date
          2011-08-12 00:00:00
          Application Docs ID
          16865
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        6. Appl No
          022059
          Application Docs Date
          2013-06-25 00:00:00
          Application Docs ID
          16866
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          15
          Submission Type
          SUPPL
        7. Appl No
          022059
          Application Docs Date
          2013-06-25 00:00:00
          Application Docs ID
          16867
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          18
          Submission Type
          SUPPL
        8. Appl No
          022059
          Application Docs Date
          2015-01-05 00:00:00
          Application Docs ID
          16868
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          21
          Submission Type
          SUPPL
        9. Appl No
          022059
          Application Docs Date
          2007-03-13 00:00:00
          Application Docs ID
          38162
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        10. Appl No
          022059
          Application Docs Date
          2007-08-21 00:00:00
          Application Docs ID
          38163
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        11. Appl No
          022059
          Application Docs Date
          2010-02-01 00:00:00
          Application Docs ID
          38164
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        12. Appl No
          022059
          Application Docs Date
          2011-08-12 00:00:00
          Application Docs ID
          38165
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          12
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          022059
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          31
          Submission Status
          AP
          Submission Status Date
          2022-03-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          022059
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          24
          Submission Status
          AP
          Submission Status Date
          2018-12-06 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          022059
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          23
          Submission Status
          AP
          Submission Status Date
          2018-12-06 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          022059
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          22
          Submission Status
          AP
          Submission Status Date
          2017-04-06 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          022059
          Review Priority
          901 REQUIRED
          Submission Class Code ID
          3
          Submission No
          21
          Submission Status
          AP
          Submission Status Date
          2014-12-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          022059
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          20
          Submission Status
          AP
          Submission Status Date
          2015-03-31 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          022059
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          18
          Submission Status
          AP
          Submission Status Date
          2013-06-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          022059
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          17
          Submission Status
          AP
          Submission Status Date
          2013-10-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          022059
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          16
          Submission Status
          AP
          Submission Status Date
          2013-10-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          022059
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          15
          Submission Status
          AP
          Submission Status Date
          2013-06-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          022059
          Review Priority
          UNKNOWN
          Submission Class Code ID
          3
          Submission No
          13
          Submission Status
          AP
          Submission Status Date
          2012-03-02 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          022059
          Review Priority
          UNKNOWN
          Submission Class Code ID
          3
          Submission No
          12
          Submission Status
          AP
          Submission Status Date
          2011-08-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA022059
        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
        2022-03-27
        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
          022059
          Application Docs Date
          2022-03-28 00:00:00
          Application Docs ID
          70623
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          31
          Submission Type
          SUPPL
        official application record
        Appl No
        022059
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        NOVARTIS
        openfda application present
        true
        products
        1. Active Ingredient
          LAPATINIB DITOSYLATE
          Appl No
          022059
          Drug Name
          TYKERB
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 250MG 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. NDA022059
      brand names
      1. TYKERB
      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
      516
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE TYKERB ® is indicated in combination with: capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use : Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine. letrozole for the treatment of postmenopaus
      label id
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      source text sha256
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      start
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      current approval status
      not_reconciled
      duplicate text group
      dup-8831304318d98a7bda6d
      extraction review status
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      generic names
      1. LAPATINIB
      id
      ind-span-17b037c07e491029ada7
      label id
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      positive predicate support span
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      exact text
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      qualifier mentions
      1. context exact
        capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and w
        kind
        biomarker
        polarity
        not_inferred
        span
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        170
        end exclusive
        true
        exact text
        metastatic breast cancer whose tumors overe
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      2. context exact
        umors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab.
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        260
        end exclusive
        true
        exact text
        HER2) and who have received prior therapy
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      3. context exact
        ation with: capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2
        kind
        stage_or_setting
        polarity
        not_inferred
        span
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        158
        end exclusive
        true
        exact text
        advanced or metastatic breast cancer whose
        label id
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      4. context exact
        express human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab.
        kind
        prior_therapy_or_line
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        not_inferred
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        315
        end exclusive
        true
        exact text
        who have received prior therapy, including an anthracycline, a taxane, and trastuzumab
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      5. context exact
        1 INDICATIONS AND USAGE TYKERB ® is indicated in combination with: capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycl
        kind
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        end exclusive
        true
        exact text
        in combination with: capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2)
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      regulatory links
        schema version
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        source defined aliases
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          exact text
          1 INDICATIONS AND USAGE TYKERB ® is indicated in combination with: capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab.
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          source url
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          spl effective date
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          spl set id
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          spl version
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          structured fields status
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          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. NDA022059
          brand names
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          classification reasons
          1. explicit_positive_indication_predicate
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          exact text
          vanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use : Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine. letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer. TYKERB is a kinase inhibitor in
          label id
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                              TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.
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                              spl effective date
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                              Preserved source evidence · Not medical advice