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LABELS · 03fee098-20c7-4a04-81a7-06fb7d8b1470

COMETRIQ

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
2025-10-18
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 COMETRIQ is indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). COMETRIQ is a kinase inhibitor indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). ( 1 )
Full extracted label fields
application numbers
  1. NDA203756
boxed warning exact
    brand names
    1. COMETRIQ
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a0c3bea-c87b-4d25-bb44-5f0174da6b34
    generic names
    1. CABOZANTINIB
    id
    03fee098-20c7-4a04-81a7-06fb7d8b1470
    indications and usage exact
    1. 1 INDICATIONS AND USAGE COMETRIQ is indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). COMETRIQ is a kinase inhibitor indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Exelixis, Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 42388-011-14
      2. 42388-012-14
      3. 42388-013-14
      product ndcs
      1. 42388-011
      2. 42388-012
      3. 42388-013
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions ( 5.6 ) 10/2025
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 1363273
      2. 1363279
      3. 1363281
      4. 1363284
      5. 1363312
      6. 1363408
      7. 1363409
      8. 1363410
      9. 1364580
      10. 1364581
      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%2203fee098-20c7-4a04-81a7-06fb7d8b1470%22
      spl effective date
      2025-10-18
      spl effective time
      20251018
      spl set id
      1a0c3bea-c87b-4d25-bb44-5f0174da6b34
      spl version
      16
      substance names
      1. CABOZANTINIB S-MALATE
      uniis
      1. DR7ST46X58
      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
        NDA203756
        payload
        all indexed label documents
        1. Appl No
          203756
          Application Docs Date
          2012-11-30 00:00:00
          Application Docs ID
          40325
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          203756
          Application Docs Date
          2016-05-23 00:00:00
          Application Docs ID
          40326
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        3. Appl No
          203756
          Application Docs Date
          2017-10-06 00:00:00
          Application Docs ID
          49961
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        4. Appl No
          203756
          Application Docs Date
          2018-01-17 00:00:00
          Application Docs ID
          51071
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        5. Appl No
          203756
          Application Docs Date
          2020-02-03 00:00:00
          Application Docs ID
          61759
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        6. Appl No
          203756
          Application Docs Date
          2020-10-27 00:00:00
          Application Docs ID
          65036
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          9
          Submission Type
          SUPPL
        7. Appl No
          203756
          Application Docs Date
          2023-08-24 00:00:00
          Application Docs ID
          75283
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        8. Appl No
          203756
          Application Docs Date
          2025-10-09 00:00:00
          Application Docs ID
          83712
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          13
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          203756
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          13
          Submission Status
          AP
          Submission Status Date
          2025-10-09 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          203756
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          11
          Submission Status
          AP
          Submission Status Date
          2023-08-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          203756
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          9
          Submission Status
          AP
          Submission Status Date
          2020-10-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          203756
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
          2020-01-31 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          203756
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          2018-01-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          203756
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2017-10-05 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          203756
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2016-05-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          203756
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2014-02-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          203756
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2012-11-29 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        application number
        NDA203756
        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
        2025-10-09
        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
          203756
          Application Docs Date
          2025-10-09 00:00:00
          Application Docs ID
          83712
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          13
          Submission Type
          SUPPL
        official application record
        Appl No
        203756
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        EXELIXIS
        openfda application present
        true
        products
        1. Active Ingredient
          CABOZANTINIB S-MALATE
          Appl No
          203756
          Drug Name
          COMETRIQ
          Form
          CAPSULE;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          EQ 20MG BASE
          marketing status
          1. Prescription
        2. Active Ingredient
          CABOZANTINIB S-MALATE
          Appl No
          203756
          Drug Name
          COMETRIQ
          Form
          CAPSULE;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 80MG 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. NDA203756
      brand names
      1. COMETRIQ
      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
      274
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE COMETRIQ is indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). COMETRIQ is a kinase inhibitor indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). ( 1 )
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      current approval status
      not_reconciled
      duplicate text group
      dup-3386db1715bbcaa7132b
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. CABOZANTINIB
      id
      ind-span-a1746e861650c7b0432a
      label id
      03fee098-20c7-4a04-81a7-06fb7d8b1470
      positive predicate support span
      end
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      end exclusive
      true
      exact text
      is indicated
      label id
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      unicode_code_points
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      source text sha256
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      qualifier mentions
      1. context exact
        s indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC).
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        135
        end exclusive
        true
        exact text
        metastatic medullary thyroid cancer (MTC)
        label id
        03fee098-20c7-4a04-81a7-06fb7d8b1470
        offset unit
        unicode_code_points
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        source text sha256
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      2. context exact
        s indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC).
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        135
        end exclusive
        true
        exact text
        metastatic medullary thyroid cancer (MTC)
        label id
        03fee098-20c7-4a04-81a7-06fb7d8b1470
        offset unit
        unicode_code_points
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        source field
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        source text sha256
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      regulatory links
        schema version
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        source batch sha256
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        source defined aliases
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          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE COMETRIQ is indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC).
          label id
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          offset unit
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          source field
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          source text sha256
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          start
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          source url
          https://api.fda.gov/drug/label.json?search=id%3A%2203fee098-20c7-4a04-81a7-06fb7d8b1470%22
          spl effective date
          2025-10-18
          spl set id
          1a0c3bea-c87b-4d25-bb44-5f0174da6b34
          spl version
          16
          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. NDA203756
          brand names
          1. COMETRIQ
          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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          274
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE COMETRIQ is indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). COMETRIQ is a kinase inhibitor indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). ( 1 )
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          id
          ind-span-69b3adb34a3101f378f7
          label id
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          positive predicate support span
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          end exclusive
          true
          exact text
          is a kinase inhibitor indicated
          label id
          03fee098-20c7-4a04-81a7-06fb7d8b1470
          offset unit
          unicode_code_points
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          qualifier mentions
          1. context exact
            r indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC).
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            267
            end exclusive
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            exact text
            metastatic medullary thyroid cancer (MTC)
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          2. context exact
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            kind
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            span
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            end exclusive
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          regulatory links
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              exact text
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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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              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
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              Passage 3 · unclassified context
              application numbers
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              brand names
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              clinical review status
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              end exclusive
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              exact text
              tients with progressive, metastatic medullary thyroid cancer (MTC). COMETRIQ is a kinase inhibitor indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). ( 1 )
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              positive predicate support span
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                    end exclusive
                    true
                    exact text
                    ( 1 )
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                    offset unit
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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
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                    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
                    unclear

                    Preserved source evidence · Not medical advice