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LABELS · 0df064bb-358d-4c21-8525-9b8b9a5845a1

TABRECTA

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
2025-12-15
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 TABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. TABRECTA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
Full extracted label fields
application numbers
  1. NDA213591
boxed warning exact
    brand names
    1. TABRECTA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=455892c3-d144-4ba8-9ab4-79cabff9876d
    generic names
    1. CAPMATINIB
    id
    0df064bb-358d-4c21-8525-9b8b9a5845a1
    indications and usage exact
    1. 1 INDICATIONS AND USAGE TABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. TABRECTA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
    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. 0078-0709-56
      2. 0078-0709-94
      3. 0078-0716-56
      4. 0078-0716-94
      product ndcs
      1. 0078-0709
      2. 0078-0716
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 2362234
        2. 2362240
        3. 2362242
        4. 2362244
        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
        0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
        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=0&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%220df064bb-358d-4c21-8525-9b8b9a5845a1%22
        spl effective date
        2025-12-15
        spl effective time
        20251215
        spl set id
        455892c3-d144-4ba8-9ab4-79cabff9876d
        spl version
        17
        substance names
        1. CAPMATINIB HYDROCHLORIDE
        uniis
        1. C2A374O70X
        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
          NDA213591
          payload
          all indexed label documents
          1. Appl No
            213591
            Application Docs Date
            2020-05-06 00:00:00
            Application Docs ID
            62842
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            213591
            Application Docs Date
            2022-01-25 00:00:00
            Application Docs ID
            69968
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            SUPPL
          3. Appl No
            213591
            Application Docs Date
            2022-08-11 00:00:00
            Application Docs ID
            71789
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            4
            Submission Type
            SUPPL
          4. Appl No
            213591
            Application Docs Date
            2023-03-27 00:00:00
            Application Docs ID
            73884
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            7
            Submission Type
            SUPPL
          5. Appl No
            213591
            Application Docs Date
            2024-03-21 00:00:00
            Application Docs ID
            77892
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            11
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            213591
            Review Priority
            PRIORITY
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2020-05-06 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            213591
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2022-01-21 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            213591
            Review Priority
            PRIORITY
            Submission Class Code ID
            2
            Submission No
            4
            Submission Status
            AP
            Submission Status Date
            2022-08-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            213591
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            7
            Submission Status
            AP
            Submission Status Date
            2023-03-24 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            213591
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            11
            Submission Status
            AP
            Submission Status Date
            2024-03-14 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA213591
          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
          2024-03-14
          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
            213591
            Application Docs Date
            2024-03-21 00:00:00
            Application Docs ID
            77892
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            11
            Submission Type
            SUPPL
          official application record
          Appl No
          213591
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          NOVARTIS PHARM
          openfda application present
          true
          products
          1. Active Ingredient
            CAPMATINIB HYDROCHLORIDE
            Appl No
            213591
            Drug Name
            TABRECTA
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            EQ 150MG BASE
            marketing status
            1. Prescription
          2. Active Ingredient
            CAPMATINIB HYDROCHLORIDE
            Appl No
            213591
            Drug Name
            TABRECTA
            Form
            TABLET;ORAL
            Product No
            002
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 200MG 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. NDA213591
        brand names
        1. TABRECTA
        classification reasons
        1. explicit_positive_indication_predicate
        2. tumor_or_malignant_hematology_words_in_positive_statement
        clinical review status
        pending
        content role
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        context span
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        469
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE TABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. TABRECTA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial trans
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        current approval status
        not_reconciled
        duplicate text group
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        extraction review status
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        generic names
        1. CAPMATINIB
        id
        ind-span-1804a28720c85fb66f69
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        exact text
        is indicated
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        qualifier mentions
        1. context exact
          ATIONS AND USAGE TABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tu
          kind
          age
          polarity
          not_inferred
          span
          end
          81
          end exclusive
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          exact text
          adult patients
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        2. context exact
          RECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-ep
          kind
          biomarker
          polarity
          not_inferred
          span
          end
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          end exclusive
          true
          exact text
          metastatic non-small cell lung cancer (NSCL
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        3. context exact
          a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
          kind
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          end
          254
          end exclusive
          true
          exact text
          MET) exon 14 skipping as detected by an FDA
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        4. context exact
          RECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epit
          kind
          stage_or_setting
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          not_inferred
          span
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          end exclusive
          true
          exact text
          metastatic non-small cell lung cancer (NSCLC)
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        regulatory links
          schema version
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          source batch sha256
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          source defined aliases
          1. abbreviation
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            definition exact
            non-small cell lung cancer
            definition span
            end
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            true
            exact text
            non-small cell lung cancer (NSCLC)
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          1 INDICATIONS AND USAGE TABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
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          source url
          https://api.fda.gov/drug/label.json?search=id%3A%220df064bb-358d-4c21-8525-9b8b9a5845a1%22
          spl effective date
          2025-12-15
          spl set id
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          spl version
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          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. NDA213591
          brand names
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          lt patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. TABRECTA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
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          current approval status
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          id
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          is a kinase inhibitor indicated
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          qualifier mentions
          1. context exact
            BRECTA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tu
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            polarity
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            end
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          4. context exact
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            exact text
            TABRECTA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
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            source url
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            spl effective date
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            spl set id
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            structured fields status
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            structured indication
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            Source null
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            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

            Preserved source evidence · Not medical advice