Skip to content
Triangle logo TriangleGet started
← Back to this collection

LABELS · 9fa5a47f-24bf-464a-aed7-54ad81abf121

Augtyro

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
2024-06-13
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE AUGTYRO is a kinase inhibitor indicated for the treatment of • adult patients with locally advanced or metastatic ROS1- positive non-small cell lung cancer (NSCLC). ( 1.1 ) • adult and pediatric patients 12 years of age and older with solid tumors that: • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion and • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity. • have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. ( 1.2 ) 1.1 ROS1 -Positive Non-Small Cell Lung Cancer AUGTYRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) [see Dosage and Administration (2.1) ] . 1.2 NTRK Gene Fusion-Positive Solid Tumors AUGTYRO is indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that: • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion [see Dosage and Administration ( 2.1 )] , • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and • have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14.2 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Full extracted label fields
application numbers
  1. NDA218213
boxed warning exact
    brand names
    1. Augtyro
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb526827-40ba-4462-94cf-179ae3b0cb8a
    generic names
    1. REPOTRECTINIB
    id
    9fa5a47f-24bf-464a-aed7-54ad81abf121
    indications and usage exact
    1. 1 INDICATIONS AND USAGE AUGTYRO is a kinase inhibitor indicated for the treatment of • adult patients with locally advanced or metastatic ROS1- positive non-small cell lung cancer (NSCLC). ( 1.1 ) • adult and pediatric patients 12 years of age and older with solid tumors that: • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion and • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity. • have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. ( 1.2 ) 1.1 ROS1 -Positive Non-Small Cell Lung Cancer AUGTYRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) [see Dosage and Administration (2.1) ] . 1.2 NTRK Gene Fusion-Positive Solid Tumors AUGTYRO is indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that: • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion [see Dosage and Administration ( 2.1 )] , • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and • have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14.2 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. E.R. Squibb & Sons, L.L.C.
      matched search terms
      1. cancer
      2. tumors
      package ndcs
      1. 0003-4040-60
      2. 0003-4040-12
      3. 0003-4160-14
      4. 0003-4160-60
      product ndcs
      1. 0003-4040
      2. 0003-4160
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Indications and Usage ( 1.2 ) 06/2024 Dosage and Administration ( 2.1 ) 06/2024 Warnings and Precautions ( 5.6 ) 06/2024
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 2670649
      2. 2670655
      3. 2696876
      4. 2696878
      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
      100
      skip
      500
      total
      830
      sha256
      424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
      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=500&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%229fa5a47f-24bf-464a-aed7-54ad81abf121%22
      spl effective date
      2024-06-13
      spl effective time
      20240613
      spl set id
      fb526827-40ba-4462-94cf-179ae3b0cb8a
      spl version
      6
      substance names
      1. REPOTRECTINIB
      uniis
      1. 08O3FQ4UNP
      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
        NDA218213
        payload
        all indexed label documents
        1. Appl No
          218213
          Application Docs Date
          2023-11-16 00:00:00
          Application Docs ID
          77170
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          218213
          Application Docs Date
          2024-06-13 00:00:00
          Application Docs ID
          78797
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          218213
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2024-06-13 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          218213
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2023-11-15 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        application number
        NDA218213
        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
        2024-06-13
        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
          218213
          Application Docs Date
          2024-06-13 00:00:00
          Application Docs ID
          78797
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        official application record
        Appl No
        218213
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        BRISTOL
        openfda application present
        true
        products
        1. Active Ingredient
          REPOTRECTINIB
          Appl No
          218213
          Drug Name
          AUGTYRO
          Form
          CAPSULE;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          40MG
          marketing status
          1. Prescription
        2. Active Ingredient
          REPOTRECTINIB
          Appl No
          218213
          Drug Name
          AUGTYRO
          Form
          CAPSULE;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          160MG
          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. NDA218213
      brand names
      1. Augtyro
      classification reasons
      1. explicit_positive_indication_predicate
      2. no_tumor_directed_keyword_in_positive_statement
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      284
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE AUGTYRO is a kinase inhibitor indicated for the treatment of • adult patients with locally advanced or metastatic ROS1- positive non-small cell lung cancer (NSCLC). ( 1.1 ) • adult and pediatric patients 12 years of age and older with solid tumors that: • have
      label id
      9fa5a47f-24bf-464a-aed7-54ad81abf121
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-7fd2f613e1ab834591ff
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. REPOTRECTINIB
      id
      ind-span-0d075a97e09fab78b3cb
      label id
      9fa5a47f-24bf-464a-aed7-54ad81abf121
      positive predicate support span
      end
      63
      end exclusive
      true
      exact text
      is a kinase inhibitor indicated
      label id
      9fa5a47f-24bf-464a-aed7-54ad81abf121
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
      start
      32
      qualifier mentions
        regulatory links
          schema version
          0.1.0
          source batch sha256
          424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
          source defined aliases
          1. abbreviation
            NSCLC
            definition exact
            non-small cell lung cancer
            definition span
            end
            187
            end exclusive
            true
            exact text
            non-small cell lung cancer (NSCLC)
            label id
            9fa5a47f-24bf-464a-aed7-54ad81abf121
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
            start
            153
          source span
          end
          84
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE AUGTYRO is a kinase inhibitor indicated for the treatment of
          label id
          9fa5a47f-24bf-464a-aed7-54ad81abf121
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
          start
          0
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%229fa5a47f-24bf-464a-aed7-54ad81abf121%22
          spl effective date
          2024-06-13
          spl set id
          fb526827-40ba-4462-94cf-179ae3b0cb8a
          spl version
          6
          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
          non_oncology_or_unclear_candidate
          Passage 2 · unclassified context
          application numbers
          1. NDA218213
          brand names
          1. Augtyro
          classification reasons
          1. no_unambiguous_positive_indication_predicate
          clinical review status
          pending
          content role
          unclassified_context
          context span
          end
          388
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE AUGTYRO is a kinase inhibitor indicated for the treatment of • adult patients with locally advanced or metastatic ROS1- positive non-small cell lung cancer (NSCLC). ( 1.1 ) • adult and pediatric patients 12 years of age and older with solid tumors that: • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion and • are locally advanced or metastatic o
          label id
          9fa5a47f-24bf-464a-aed7-54ad81abf121
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
          start
          0
          current approval status
          not_reconciled
          duplicate text group
          dup-96e014d637ca8ba15217
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. REPOTRECTINIB
          id
          ind-span-135c1a38b558f3bcad0c
          label id
          9fa5a47f-24bf-464a-aed7-54ad81abf121
          positive predicate support span
          Source null
          qualifier mentions
          1. context exact
            • adult patients with locally advanced or metastatic ROS1- positive non-smal
            kind
            age
            polarity
            not_inferred
            span
            end
            101
            end exclusive
            true
            exact text
            adult patients
            label id
            9fa5a47f-24bf-464a-aed7-54ad81abf121
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
            start
            87
          2. context exact
            • adult patients with locally advanced or metastatic ROS1- positive non-small cell lung cancer (NSCLC).
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            170
            end exclusive
            true
            exact text
            metastatic ROS1- positive non-small cell lu
            label id
            9fa5a47f-24bf-464a-aed7-54ad81abf121
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
            start
            127
          3. context exact
            • adult patients with locally advanced or metastatic ROS1- positive non-small cell lung cancer (NSCLC).
            kind
            stage_or_setting
            polarity
            not_inferred
            span
            end
            158
            end exclusive
            true
            exact text
            locally advanced or metastatic ROS1- positive non-s
            label id
            9fa5a47f-24bf-464a-aed7-54ad81abf121
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
            start
            107
          regulatory links
            schema version
            0.1.0
            source batch sha256
            424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
            source defined aliases
            1. abbreviation
              NSCLC
              definition exact
              non-small cell lung cancer
              definition span
              end
              187
              end exclusive
              true
              exact text
              non-small cell lung cancer (NSCLC)
              label id
              9fa5a47f-24bf-464a-aed7-54ad81abf121
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
              start
              153
            source span
            end
            188
            end exclusive
            true
            exact text
            • adult patients with locally advanced or metastatic ROS1- positive non-small cell lung cancer (NSCLC).
            label id
            9fa5a47f-24bf-464a-aed7-54ad81abf121
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
            start
            85
            source url
            https://api.fda.gov/drug/label.json?search=id%3A%229fa5a47f-24bf-464a-aed7-54ad81abf121%22
            spl effective date
            2024-06-13
            spl set id
            fb526827-40ba-4462-94cf-179ae3b0cb8a
            spl version
            6
            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
            unclear
            Passage 3 · unclassified context
            application numbers
            1. NDA218213
            brand names
            1. Augtyro
            classification reasons
            1. no_unambiguous_positive_indication_predicate
            clinical review status
            pending
            content role
            unclassified_context
            context span
            end
            396
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE AUGTYRO is a kinase inhibitor indicated for the treatment of • adult patients with locally advanced or metastatic ROS1- positive non-small cell lung cancer (NSCLC). ( 1.1 ) • adult and pediatric patients 12 years of age and older with solid tumors that: • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion and • are locally advanced or metastatic or where
            label id
            9fa5a47f-24bf-464a-aed7-54ad81abf121
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
            start
            0
            current approval status
            not_reconciled
            duplicate text group
            dup-3c9b0f5efce290f800ee
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. REPOTRECTINIB
            id
            ind-span-68f936e18b03119c6316
            label id
            9fa5a47f-24bf-464a-aed7-54ad81abf121
            positive predicate support span
            Source null
            qualifier mentions
              regulatory links
                schema version
                0.1.0
                source batch sha256
                424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                source defined aliases
                1. abbreviation
                  NSCLC
                  definition exact
                  non-small cell lung cancer
                  definition span
                  end
                  187
                  end exclusive
                  true
                  exact text
                  non-small cell lung cancer (NSCLC)
                  label id
                  9fa5a47f-24bf-464a-aed7-54ad81abf121
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                  start
                  153
                source span
                end
                196
                end exclusive
                true
                exact text
                ( 1.1 )
                label id
                9fa5a47f-24bf-464a-aed7-54ad81abf121
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                start
                189
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%229fa5a47f-24bf-464a-aed7-54ad81abf121%22
                spl effective date
                2024-06-13
                spl set id
                fb526827-40ba-4462-94cf-179ae3b0cb8a
                spl version
                6
                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
                unclear
                Passage 4 · unclassified context
                application numbers
                1. NDA218213
                brand names
                1. Augtyro
                classification reasons
                1. no_unambiguous_positive_indication_predicate
                clinical review status
                pending
                content role
                unclassified_context
                context span
                end
                477
                end exclusive
                true
                exact text
                1 INDICATIONS AND USAGE AUGTYRO is a kinase inhibitor indicated for the treatment of • adult patients with locally advanced or metastatic ROS1- positive non-small cell lung cancer (NSCLC). ( 1.1 ) • adult and pediatric patients 12 years of age and older with solid tumors that: • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion and • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity. • have progressed fol
                label id
                9fa5a47f-24bf-464a-aed7-54ad81abf121
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                start
                0
                current approval status
                not_reconciled
                duplicate text group
                dup-e2297d32b3f786a86ccd
                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. REPOTRECTINIB
                id
                ind-span-451ca2c3efb4b982d4c7
                label id
                9fa5a47f-24bf-464a-aed7-54ad81abf121
                positive predicate support span
                Source null
                qualifier mentions
                1. context exact
                  • adult and pediatric patients 12 years of age and older with solid
                  kind
                  age
                  polarity
                  not_inferred
                  span
                  end
                  204
                  end exclusive
                  true
                  exact text
                  adult
                  label id
                  9fa5a47f-24bf-464a-aed7-54ad81abf121
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                  start
                  199
                2. context exact
                  • adult and pediatric patients 12 years of age and older with solid tumors that:
                  kind
                  age
                  polarity
                  not_inferred
                  span
                  end
                  227
                  end exclusive
                  true
                  exact text
                  pediatric patients
                  label id
                  9fa5a47f-24bf-464a-aed7-54ad81abf121
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                  start
                  209
                3. context exact
                  • adult and pediatric patients 12 years of age and older with solid tumors that:
                  kind
                  age
                  polarity
                  not_inferred
                  span
                  end
                  243
                  end exclusive
                  true
                  exact text
                  12 years of age
                  label id
                  9fa5a47f-24bf-464a-aed7-54ad81abf121
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                  start
                  228
                regulatory links
                  schema version
                  0.1.0
                  source batch sha256
                  424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                  source defined aliases
                  1. abbreviation
                    NSCLC
                    definition exact
                    non-small cell lung cancer
                    definition span
                    end
                    187
                    end exclusive
                    true
                    exact text
                    non-small cell lung cancer (NSCLC)
                    label id
                    9fa5a47f-24bf-464a-aed7-54ad81abf121
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                    start
                    153
                  source span
                  end
                  277
                  end exclusive
                  true
                  exact text
                  • adult and pediatric patients 12 years of age and older with solid tumors that:
                  label id
                  9fa5a47f-24bf-464a-aed7-54ad81abf121
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                  start
                  197
                  source url
                  https://api.fda.gov/drug/label.json?search=id%3A%229fa5a47f-24bf-464a-aed7-54ad81abf121%22
                  spl effective date
                  2024-06-13
                  spl set id
                  fb526827-40ba-4462-94cf-179ae3b0cb8a
                  spl version
                  6
                  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
                  unclear
                  Passage 5 · unclassified context
                  application numbers
                  1. NDA218213
                  brand names
                  1. Augtyro
                  classification reasons
                  1. no_unambiguous_positive_indication_predicate
                  clinical review status
                  pending
                  content role
                  unclassified_context
                  context span
                  end
                  549
                  end exclusive
                  true
                  exact text
                  ent of • adult patients with locally advanced or metastatic ROS1- positive non-small cell lung cancer (NSCLC). ( 1.1 ) • adult and pediatric patients 12 years of age and older with solid tumors that: • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion and • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity. • have progressed following treatment or have no satisfactory alternative therapy. This indic
                  label id
                  9fa5a47f-24bf-464a-aed7-54ad81abf121
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                  start
                  78
                  current approval status
                  not_reconciled
                  duplicate text group
                  dup-a3ebd49e4afe8134602b
                  extraction review status
                  automated_candidate_pending_source_review
                  generic names
                  1. REPOTRECTINIB
                  id
                  ind-span-741bcbc881d24bbbd339
                  label id
                  9fa5a47f-24bf-464a-aed7-54ad81abf121
                  positive predicate support span
                  Source null
                  qualifier mentions
                  1. context exact
                    • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion and
                    kind
                    biomarker
                    polarity
                    not_inferred
                    span
                    end
                    349
                    end exclusive
                    true
                    exact text
                    NTRK ) gene fusion and
                    label id
                    9fa5a47f-24bf-464a-aed7-54ad81abf121
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                    start
                    327
                  regulatory links
                    schema version
                    0.1.0
                    source batch sha256
                    424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                    source defined aliases
                    1. abbreviation
                      NSCLC
                      definition exact
                      non-small cell lung cancer
                      definition span
                      end
                      187
                      end exclusive
                      true
                      exact text
                      non-small cell lung cancer (NSCLC)
                      label id
                      9fa5a47f-24bf-464a-aed7-54ad81abf121
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                      start
                      153
                    source span
                    end
                    349
                    end exclusive
                    true
                    exact text
                    • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion and
                    label id
                    9fa5a47f-24bf-464a-aed7-54ad81abf121
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                    start
                    278
                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%229fa5a47f-24bf-464a-aed7-54ad81abf121%22
                    spl effective date
                    2024-06-13
                    spl set id
                    fb526827-40ba-4462-94cf-179ae3b0cb8a
                    spl version
                    6
                    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
                    unclear
                    Passage 6 · unclassified context
                    application numbers
                    1. NDA218213
                    brand names
                    1. Augtyro
                    classification reasons
                    1. no_unambiguous_positive_indication_predicate
                    clinical review status
                    pending
                    content role
                    unclassified_context
                    context span
                    end
                    655
                    end exclusive
                    true
                    exact text
                    ve non-small cell lung cancer (NSCLC). ( 1.1 ) • adult and pediatric patients 12 years of age and older with solid tumors that: • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion and • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity. • have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Cont
                    label id
                    9fa5a47f-24bf-464a-aed7-54ad81abf121
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                    start
                    150
                    current approval status
                    not_reconciled
                    duplicate text group
                    dup-8bea545df334d34bae81
                    extraction review status
                    automated_candidate_pending_source_review
                    generic names
                    1. REPOTRECTINIB
                    id
                    ind-span-28595ad67d7b990766eb
                    label id
                    9fa5a47f-24bf-464a-aed7-54ad81abf121
                    positive predicate support span
                    Source null
                    qualifier mentions
                    1. context exact
                      • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity.
                      kind
                      biomarker
                      polarity
                      not_inferred
                      span
                      end
                      419
                      end exclusive
                      true
                      exact text
                      metastatic or where surgical resection is l
                      label id
                      9fa5a47f-24bf-464a-aed7-54ad81abf121
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                      start
                      376
                    2. context exact
                      • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity.
                      kind
                      stage_or_setting
                      polarity
                      not_inferred
                      span
                      end
                      407
                      end exclusive
                      true
                      exact text
                      locally advanced or metastatic or where surgical re
                      label id
                      9fa5a47f-24bf-464a-aed7-54ad81abf121
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                      start
                      356
                    regulatory links
                      schema version
                      0.1.0
                      source batch sha256
                      424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                      source defined aliases
                      1. abbreviation
                        NSCLC
                        definition exact
                        non-small cell lung cancer
                        definition span
                        end
                        187
                        end exclusive
                        true
                        exact text
                        non-small cell lung cancer (NSCLC)
                        label id
                        9fa5a47f-24bf-464a-aed7-54ad81abf121
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                        start
                        153
                      source span
                      end
                      455
                      end exclusive
                      true
                      exact text
                      • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity.
                      label id
                      9fa5a47f-24bf-464a-aed7-54ad81abf121
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                      start
                      350
                      source url
                      https://api.fda.gov/drug/label.json?search=id%3A%229fa5a47f-24bf-464a-aed7-54ad81abf121%22
                      spl effective date
                      2024-06-13
                      spl set id
                      fb526827-40ba-4462-94cf-179ae3b0cb8a
                      spl version
                      6
                      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
                      unclear
                      Passage 7 · unclassified context
                      application numbers
                      1. NDA218213
                      brand names
                      1. Augtyro
                      classification reasons
                      1. no_unambiguous_positive_indication_predicate
                      clinical review status
                      pending
                      content role
                      unclassified_context
                      context span
                      end
                      738
                      end exclusive
                      true
                      exact text
                      th solid tumors that: • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion and • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity. • have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and descript
                      label id
                      9fa5a47f-24bf-464a-aed7-54ad81abf121
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                      start
                      256
                      current approval status
                      not_reconciled
                      duplicate text group
                      dup-b1225c7c0f1a81b20bb4
                      extraction review status
                      automated_candidate_pending_source_review
                      generic names
                      1. REPOTRECTINIB
                      id
                      ind-span-b617233a259a10ace1c0
                      label id
                      9fa5a47f-24bf-464a-aed7-54ad81abf121
                      positive predicate support span
                      Source null
                      qualifier mentions
                      1. context exact
                        • have progressed following treatment or have no satisfactory alternative therapy.
                        kind
                        prior_therapy_or_line
                        polarity
                        not_inferred
                        span
                        end
                        537
                        end exclusive
                        true
                        exact text
                        no satisfactory alternative therapy
                        label id
                        9fa5a47f-24bf-464a-aed7-54ad81abf121
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                        start
                        502
                      regulatory links
                        schema version
                        0.1.0
                        source batch sha256
                        424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                        source defined aliases
                        1. abbreviation
                          NSCLC
                          definition exact
                          non-small cell lung cancer
                          definition span
                          end
                          187
                          end exclusive
                          true
                          exact text
                          non-small cell lung cancer (NSCLC)
                          label id
                          9fa5a47f-24bf-464a-aed7-54ad81abf121
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                          start
                          153
                        source span
                        end
                        538
                        end exclusive
                        true
                        exact text
                        • have progressed following treatment or have no satisfactory alternative therapy.
                        label id
                        9fa5a47f-24bf-464a-aed7-54ad81abf121
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                        start
                        456
                        source url
                        https://api.fda.gov/drug/label.json?search=id%3A%229fa5a47f-24bf-464a-aed7-54ad81abf121%22
                        spl effective date
                        2024-06-13
                        spl set id
                        fb526827-40ba-4462-94cf-179ae3b0cb8a
                        spl version
                        6
                        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
                        unclear
                        Passage 8 · approval contingency
                        application numbers
                        1. NDA218213
                        brand names
                        1. Augtyro
                        classification reasons
                        1. approval_contingency_words
                        clinical review status
                        pending
                        content role
                        approval_contingency
                        context span
                        end
                        850
                        end exclusive
                        true
                        exact text
                        fusion and • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity. • have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. ( 1.2 ) 1.1 ROS1 -Positive Non-Small Cell Lung Cancer AUGTYR
                        label id
                        9fa5a47f-24bf-464a-aed7-54ad81abf121
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                        start
                        339
                        current approval status
                        not_reconciled
                        duplicate text group
                        dup-ea53feb72c0e3a581a39
                        extraction review status
                        automated_candidate_pending_source_review
                        generic names
                        1. REPOTRECTINIB
                        id
                        ind-span-2f5c34955f5558f2a54f
                        label id
                        9fa5a47f-24bf-464a-aed7-54ad81abf121
                        positive predicate support span
                        Source null
                        qualifier mentions
                          regulatory links
                            schema version
                            0.1.0
                            source batch sha256
                            424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                            source defined aliases
                            1. abbreviation
                              NSCLC
                              definition exact
                              non-small cell lung cancer
                              definition span
                              end
                              187
                              end exclusive
                              true
                              exact text
                              non-small cell lung cancer (NSCLC)
                              label id
                              9fa5a47f-24bf-464a-aed7-54ad81abf121
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                              start
                              153
                            source span
                            end
                            650
                            end exclusive
                            true
                            exact text
                            This indication is approved under accelerated approval based on overall response rate and duration of response.
                            label id
                            9fa5a47f-24bf-464a-aed7-54ad81abf121
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                            start
                            539
                            source url
                            https://api.fda.gov/drug/label.json?search=id%3A%229fa5a47f-24bf-464a-aed7-54ad81abf121%22
                            spl effective date
                            2024-06-13
                            spl set id
                            fb526827-40ba-4462-94cf-179ae3b0cb8a
                            spl version
                            6
                            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
                            not_applicable
                            Passage 9 · approval contingency
                            application numbers
                            1. NDA218213
                            brand names
                            1. Augtyro
                            classification reasons
                            1. approval_contingency_words
                            clinical review status
                            pending
                            content role
                            approval_contingency
                            context span
                            end
                            989
                            end exclusive
                            true
                            exact text
                            ity. • have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. ( 1.2 ) 1.1 ROS1 -Positive Non-Small Cell Lung Cancer AUGTYRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) [s
                            label id
                            9fa5a47f-24bf-464a-aed7-54ad81abf121
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                            start
                            451
                            current approval status
                            not_reconciled
                            duplicate text group
                            dup-342174ba2c3743783395
                            extraction review status
                            automated_candidate_pending_source_review
                            generic names
                            1. REPOTRECTINIB
                            id
                            ind-span-386f315c8a2655d8531a
                            label id
                            9fa5a47f-24bf-464a-aed7-54ad81abf121
                            positive predicate support span
                            Source null
                            qualifier mentions
                              regulatory links
                                schema version
                                0.1.0
                                source batch sha256
                                424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                                source defined aliases
                                1. abbreviation
                                  NSCLC
                                  definition exact
                                  non-small cell lung cancer
                                  definition span
                                  end
                                  187
                                  end exclusive
                                  true
                                  exact text
                                  non-small cell lung cancer (NSCLC)
                                  label id
                                  9fa5a47f-24bf-464a-aed7-54ad81abf121
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                  start
                                  153
                                source span
                                end
                                789
                                end exclusive
                                true
                                exact text
                                Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
                                label id
                                9fa5a47f-24bf-464a-aed7-54ad81abf121
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                start
                                651
                                source url
                                https://api.fda.gov/drug/label.json?search=id%3A%229fa5a47f-24bf-464a-aed7-54ad81abf121%22
                                spl effective date
                                2024-06-13
                                spl set id
                                fb526827-40ba-4462-94cf-179ae3b0cb8a
                                spl version
                                6
                                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
                                not_applicable
                                Passage 10 · unclassified context
                                application numbers
                                1. NDA218213
                                brand names
                                1. Augtyro
                                classification reasons
                                1. no_unambiguous_positive_indication_predicate
                                clinical review status
                                pending
                                content role
                                unclassified_context
                                context span
                                end
                                997
                                end exclusive
                                true
                                exact text
                                val based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. ( 1.2 ) 1.1 ROS1 -Positive Non-Small Cell Lung Cancer AUGTYRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) [see Dosag
                                label id
                                9fa5a47f-24bf-464a-aed7-54ad81abf121
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                start
                                590
                                current approval status
                                not_reconciled
                                duplicate text group
                                dup-b33798f6dfba73e06e10
                                extraction review status
                                automated_candidate_pending_source_review
                                generic names
                                1. REPOTRECTINIB
                                id
                                ind-span-48888c19bce808ada029
                                label id
                                9fa5a47f-24bf-464a-aed7-54ad81abf121
                                positive predicate support span
                                Source null
                                qualifier mentions
                                  regulatory links
                                    schema version
                                    0.1.0
                                    source batch sha256
                                    424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                                    source defined aliases
                                    1. abbreviation
                                      NSCLC
                                      definition exact
                                      non-small cell lung cancer
                                      definition span
                                      end
                                      187
                                      end exclusive
                                      true
                                      exact text
                                      non-small cell lung cancer (NSCLC)
                                      label id
                                      9fa5a47f-24bf-464a-aed7-54ad81abf121
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                      start
                                      153
                                    source span
                                    end
                                    797
                                    end exclusive
                                    true
                                    exact text
                                    ( 1.2 )
                                    label id
                                    9fa5a47f-24bf-464a-aed7-54ad81abf121
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                    start
                                    790
                                    source url
                                    https://api.fda.gov/drug/label.json?search=id%3A%229fa5a47f-24bf-464a-aed7-54ad81abf121%22
                                    spl effective date
                                    2024-06-13
                                    spl set id
                                    fb526827-40ba-4462-94cf-179ae3b0cb8a
                                    spl version
                                    6
                                    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
                                    unclear
                                    Passage 11 · positive indication candidate
                                    application numbers
                                    1. NDA218213
                                    brand names
                                    1. Augtyro
                                    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
                                    1227
                                    end exclusive
                                    true
                                    exact text
                                    d on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. ( 1.2 ) 1.1 ROS1 -Positive Non-Small Cell Lung Cancer AUGTYRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) [see Dosage and Administration (2.1) ] . 1.2 NTRK Gene Fusion-Positive Solid Tumors AUGTYRO is indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that: • have a neurotrophic tyrosine rece
                                    label id
                                    9fa5a47f-24bf-464a-aed7-54ad81abf121
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                    start
                                    598
                                    current approval status
                                    not_reconciled
                                    duplicate text group
                                    dup-67356dc6952658b7e16e
                                    extraction review status
                                    automated_candidate_pending_source_review
                                    generic names
                                    1. REPOTRECTINIB
                                    id
                                    ind-span-ed68d40b0c4179401d20
                                    label id
                                    9fa5a47f-24bf-464a-aed7-54ad81abf121
                                    positive predicate support span
                                    end
                                    864
                                    end exclusive
                                    true
                                    exact text
                                    is indicated
                                    label id
                                    9fa5a47f-24bf-464a-aed7-54ad81abf121
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                    start
                                    852
                                    qualifier mentions
                                    1. context exact
                                      Cell Lung Cancer AUGTYRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-smal
                                      kind
                                      age
                                      polarity
                                      not_inferred
                                      span
                                      end
                                      900
                                      end exclusive
                                      true
                                      exact text
                                      adult patients
                                      label id
                                      9fa5a47f-24bf-464a-aed7-54ad81abf121
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                      start
                                      886
                                    2. context exact
                                      1.1 ROS1 -Positive Non-Small Cell Lung Cancer AUGTYRO is indicated for the treatment of adult patients with
                                      kind
                                      biomarker
                                      polarity
                                      not_inferred
                                      span
                                      end
                                      846
                                      end exclusive
                                      true
                                      exact text
                                      ROS1 -Positive Non-Small Cell Lung Cancer AU
                                      label id
                                      9fa5a47f-24bf-464a-aed7-54ad81abf121
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                      start
                                      802
                                    3. context exact
                                      or the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) [see Dosage and Administration (2.1) ] .
                                      kind
                                      biomarker
                                      polarity
                                      not_inferred
                                      span
                                      end
                                      969
                                      end exclusive
                                      true
                                      exact text
                                      metastatic ROS1 -positive non-small cell lu
                                      label id
                                      9fa5a47f-24bf-464a-aed7-54ad81abf121
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                      start
                                      926
                                    4. context exact
                                      GTYRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) [see Dosage and Administration
                                      kind
                                      stage_or_setting
                                      polarity
                                      not_inferred
                                      span
                                      end
                                      957
                                      end exclusive
                                      true
                                      exact text
                                      locally advanced or metastatic ROS1 -positive non-s
                                      label id
                                      9fa5a47f-24bf-464a-aed7-54ad81abf121
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                      start
                                      906
                                    regulatory links
                                      schema version
                                      0.1.0
                                      source batch sha256
                                      424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                                      source defined aliases
                                      1. abbreviation
                                        NSCLC
                                        definition exact
                                        non-small cell lung cancer
                                        definition span
                                        end
                                        187
                                        end exclusive
                                        true
                                        exact text
                                        non-small cell lung cancer (NSCLC)
                                        label id
                                        9fa5a47f-24bf-464a-aed7-54ad81abf121
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                        start
                                        153
                                      source span
                                      end
                                      1027
                                      end exclusive
                                      true
                                      exact text
                                      1.1 ROS1 -Positive Non-Small Cell Lung Cancer AUGTYRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) [see Dosage and Administration (2.1) ] .
                                      label id
                                      9fa5a47f-24bf-464a-aed7-54ad81abf121
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                      start
                                      798
                                      source url
                                      https://api.fda.gov/drug/label.json?search=id%3A%229fa5a47f-24bf-464a-aed7-54ad81abf121%22
                                      spl effective date
                                      2024-06-13
                                      spl set id
                                      fb526827-40ba-4462-94cf-179ae3b0cb8a
                                      spl version
                                      6
                                      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 12 · positive indication candidate
                                      application numbers
                                      1. NDA218213
                                      brand names
                                      1. Augtyro
                                      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
                                      1391
                                      end exclusive
                                      true
                                      exact text
                                      ell Lung Cancer AUGTYRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) [see Dosage and Administration (2.1) ] . 1.2 NTRK Gene Fusion-Positive Solid Tumors AUGTYRO is indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that: • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion [see Dosage and Administration ( 2.1 )] , • are locally advanced or metastatic or where surgical resection is likely to result in s
                                      label id
                                      9fa5a47f-24bf-464a-aed7-54ad81abf121
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                      start
                                      828
                                      current approval status
                                      not_reconciled
                                      duplicate text group
                                      dup-eded25731eee0a1186b8
                                      extraction review status
                                      automated_candidate_pending_source_review
                                      generic names
                                      1. REPOTRECTINIB
                                      id
                                      ind-span-4640c3554ec53ca2b949
                                      label id
                                      9fa5a47f-24bf-464a-aed7-54ad81abf121
                                      positive predicate support span
                                      end
                                      1091
                                      end exclusive
                                      true
                                      exact text
                                      is indicated
                                      label id
                                      9fa5a47f-24bf-464a-aed7-54ad81abf121
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                      start
                                      1079
                                      qualifier mentions
                                      1. context exact
                                        tive Solid Tumors AUGTYRO is indicated for the treatment of adult and pediatric patients 12 years of age and older with solid
                                        kind
                                        age
                                        polarity
                                        not_inferred
                                        span
                                        end
                                        1118
                                        end exclusive
                                        true
                                        exact text
                                        adult
                                        label id
                                        9fa5a47f-24bf-464a-aed7-54ad81abf121
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                        start
                                        1113
                                      2. context exact
                                        Tumors AUGTYRO is indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that:
                                        kind
                                        age
                                        polarity
                                        not_inferred
                                        span
                                        end
                                        1141
                                        end exclusive
                                        true
                                        exact text
                                        pediatric patients
                                        label id
                                        9fa5a47f-24bf-464a-aed7-54ad81abf121
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                        start
                                        1123
                                      3. context exact
                                        indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that:
                                        kind
                                        age
                                        polarity
                                        not_inferred
                                        span
                                        end
                                        1157
                                        end exclusive
                                        true
                                        exact text
                                        12 years of age
                                        label id
                                        9fa5a47f-24bf-464a-aed7-54ad81abf121
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                        start
                                        1142
                                      4. context exact
                                        1.2 NTRK Gene Fusion-Positive Solid Tumors AUGTYRO is indicated for the treatment of adult and pediatric pat
                                        kind
                                        biomarker
                                        polarity
                                        not_inferred
                                        span
                                        end
                                        1076
                                        end exclusive
                                        true
                                        exact text
                                        NTRK Gene Fusion-Positive Solid Tumors AUGTY
                                        label id
                                        9fa5a47f-24bf-464a-aed7-54ad81abf121
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                        start
                                        1032
                                      regulatory links
                                        schema version
                                        0.1.0
                                        source batch sha256
                                        424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                                        source defined aliases
                                        1. abbreviation
                                          NSCLC
                                          definition exact
                                          non-small cell lung cancer
                                          definition span
                                          end
                                          187
                                          end exclusive
                                          true
                                          exact text
                                          non-small cell lung cancer (NSCLC)
                                          label id
                                          9fa5a47f-24bf-464a-aed7-54ad81abf121
                                          offset unit
                                          unicode_code_points
                                          source array index
                                          0
                                          source field
                                          indications_and_usage_exact
                                          source text sha256
                                          6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                          start
                                          153
                                        source span
                                        end
                                        1191
                                        end exclusive
                                        true
                                        exact text
                                        1.2 NTRK Gene Fusion-Positive Solid Tumors AUGTYRO is indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that:
                                        label id
                                        9fa5a47f-24bf-464a-aed7-54ad81abf121
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                        start
                                        1028
                                        source url
                                        https://api.fda.gov/drug/label.json?search=id%3A%229fa5a47f-24bf-464a-aed7-54ad81abf121%22
                                        spl effective date
                                        2024-06-13
                                        spl set id
                                        fb526827-40ba-4462-94cf-179ae3b0cb8a
                                        spl version
                                        6
                                        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 13 · unclassified context
                                        application numbers
                                        1. NDA218213
                                        brand names
                                        1. Augtyro
                                        classification reasons
                                        1. no_unambiguous_positive_indication_predicate
                                        clinical review status
                                        pending
                                        content role
                                        unclassified_context
                                        context span
                                        end
                                        1501
                                        end exclusive
                                        true
                                        exact text
                                        Dosage and Administration (2.1) ] . 1.2 NTRK Gene Fusion-Positive Solid Tumors AUGTYRO is indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that: • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion [see Dosage and Administration ( 2.1 )] , • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and • have progressed following treatment or have no satisfactory alternative therapy. This i
                                        label id
                                        9fa5a47f-24bf-464a-aed7-54ad81abf121
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                        start
                                        992
                                        current approval status
                                        not_reconciled
                                        duplicate text group
                                        dup-34e9332250ecc062121f
                                        extraction review status
                                        automated_candidate_pending_source_review
                                        generic names
                                        1. REPOTRECTINIB
                                        id
                                        ind-span-5fa04772535ded767a24
                                        label id
                                        9fa5a47f-24bf-464a-aed7-54ad81abf121
                                        positive predicate support span
                                        Source null
                                        qualifier mentions
                                        1. context exact
                                          • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion [see Dosage and Administration ( 2.1 )] ,
                                          kind
                                          biomarker
                                          polarity
                                          not_inferred
                                          span
                                          end
                                          1285
                                          end exclusive
                                          true
                                          exact text
                                          NTRK ) gene fusion [see Dosage and Administr
                                          label id
                                          9fa5a47f-24bf-464a-aed7-54ad81abf121
                                          offset unit
                                          unicode_code_points
                                          source array index
                                          0
                                          source field
                                          indications_and_usage_exact
                                          source text sha256
                                          6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                          start
                                          1241
                                        regulatory links
                                          schema version
                                          0.1.0
                                          source batch sha256
                                          424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                                          source defined aliases
                                          1. abbreviation
                                            NSCLC
                                            definition exact
                                            non-small cell lung cancer
                                            definition span
                                            end
                                            187
                                            end exclusive
                                            true
                                            exact text
                                            non-small cell lung cancer (NSCLC)
                                            label id
                                            9fa5a47f-24bf-464a-aed7-54ad81abf121
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                            start
                                            153
                                          source span
                                          end
                                          1301
                                          end exclusive
                                          true
                                          exact text
                                          • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion [see Dosage and Administration ( 2.1 )] ,
                                          label id
                                          9fa5a47f-24bf-464a-aed7-54ad81abf121
                                          offset unit
                                          unicode_code_points
                                          source array index
                                          0
                                          source field
                                          indications_and_usage_exact
                                          source text sha256
                                          6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                          start
                                          1192
                                          source url
                                          https://api.fda.gov/drug/label.json?search=id%3A%229fa5a47f-24bf-464a-aed7-54ad81abf121%22
                                          spl effective date
                                          2024-06-13
                                          spl set id
                                          fb526827-40ba-4462-94cf-179ae3b0cb8a
                                          spl version
                                          6
                                          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
                                          unclear
                                          Passage 14 · unclassified context
                                          application numbers
                                          1. NDA218213
                                          brand names
                                          1. Augtyro
                                          classification reasons
                                          1. no_unambiguous_positive_indication_predicate
                                          clinical review status
                                          pending
                                          content role
                                          unclassified_context
                                          context span
                                          end
                                          1611
                                          end exclusive
                                          true
                                          exact text
                                          eatment of adult and pediatric patients 12 years of age and older with solid tumors that: • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion [see Dosage and Administration ( 2.1 )] , • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and • have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see
                                          label id
                                          9fa5a47f-24bf-464a-aed7-54ad81abf121
                                          offset unit
                                          unicode_code_points
                                          source array index
                                          0
                                          source field
                                          indications_and_usage_exact
                                          source text sha256
                                          6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                          start
                                          1102
                                          current approval status
                                          not_reconciled
                                          duplicate text group
                                          dup-84d4cc3e6e29443e47c8
                                          extraction review status
                                          automated_candidate_pending_source_review
                                          generic names
                                          1. REPOTRECTINIB
                                          id
                                          ind-span-172e2b1cd6d90d9afdc8
                                          label id
                                          9fa5a47f-24bf-464a-aed7-54ad81abf121
                                          positive predicate support span
                                          Source null
                                          qualifier mentions
                                          1. context exact
                                            • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and
                                            kind
                                            biomarker
                                            polarity
                                            not_inferred
                                            span
                                            end
                                            1371
                                            end exclusive
                                            true
                                            exact text
                                            metastatic or where surgical resection is l
                                            label id
                                            9fa5a47f-24bf-464a-aed7-54ad81abf121
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                            start
                                            1328
                                          2. context exact
                                            • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and
                                            kind
                                            stage_or_setting
                                            polarity
                                            not_inferred
                                            span
                                            end
                                            1359
                                            end exclusive
                                            true
                                            exact text
                                            locally advanced or metastatic or where surgical re
                                            label id
                                            9fa5a47f-24bf-464a-aed7-54ad81abf121
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                            start
                                            1308
                                          regulatory links
                                            schema version
                                            0.1.0
                                            source batch sha256
                                            424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                                            source defined aliases
                                            1. abbreviation
                                              NSCLC
                                              definition exact
                                              non-small cell lung cancer
                                              definition span
                                              end
                                              187
                                              end exclusive
                                              true
                                              exact text
                                              non-small cell lung cancer (NSCLC)
                                              label id
                                              9fa5a47f-24bf-464a-aed7-54ad81abf121
                                              offset unit
                                              unicode_code_points
                                              source array index
                                              0
                                              source field
                                              indications_and_usage_exact
                                              source text sha256
                                              6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                              start
                                              153
                                            source span
                                            end
                                            1411
                                            end exclusive
                                            true
                                            exact text
                                            • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and
                                            label id
                                            9fa5a47f-24bf-464a-aed7-54ad81abf121
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                            start
                                            1302
                                            source url
                                            https://api.fda.gov/drug/label.json?search=id%3A%229fa5a47f-24bf-464a-aed7-54ad81abf121%22
                                            spl effective date
                                            2024-06-13
                                            spl set id
                                            fb526827-40ba-4462-94cf-179ae3b0cb8a
                                            spl version
                                            6
                                            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
                                            unclear
                                            Passage 15 · unclassified context
                                            application numbers
                                            1. NDA218213
                                            brand names
                                            1. Augtyro
                                            classification reasons
                                            1. no_unambiguous_positive_indication_predicate
                                            clinical review status
                                            pending
                                            content role
                                            unclassified_context
                                            context span
                                            end
                                            1694
                                            end exclusive
                                            true
                                            exact text
                                            c tyrosine receptor kinase ( NTRK ) gene fusion [see Dosage and Administration ( 2.1 )] , • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and • have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14.2 )] . Continued approval for this indication may be continge
                                            label id
                                            9fa5a47f-24bf-464a-aed7-54ad81abf121
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                            start
                                            1212
                                            current approval status
                                            not_reconciled
                                            duplicate text group
                                            dup-b1225c7c0f1a81b20bb4
                                            extraction review status
                                            automated_candidate_pending_source_review
                                            generic names
                                            1. REPOTRECTINIB
                                            id
                                            ind-span-76a5dd3ca074ef48c157
                                            label id
                                            9fa5a47f-24bf-464a-aed7-54ad81abf121
                                            positive predicate support span
                                            Source null
                                            qualifier mentions
                                            1. context exact
                                              • have progressed following treatment or have no satisfactory alternative therapy.
                                              kind
                                              prior_therapy_or_line
                                              polarity
                                              not_inferred
                                              span
                                              end
                                              1493
                                              end exclusive
                                              true
                                              exact text
                                              no satisfactory alternative therapy
                                              label id
                                              9fa5a47f-24bf-464a-aed7-54ad81abf121
                                              offset unit
                                              unicode_code_points
                                              source array index
                                              0
                                              source field
                                              indications_and_usage_exact
                                              source text sha256
                                              6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                              start
                                              1458
                                            regulatory links
                                              schema version
                                              0.1.0
                                              source batch sha256
                                              424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                                              source defined aliases
                                              1. abbreviation
                                                NSCLC
                                                definition exact
                                                non-small cell lung cancer
                                                definition span
                                                end
                                                187
                                                end exclusive
                                                true
                                                exact text
                                                non-small cell lung cancer (NSCLC)
                                                label id
                                                9fa5a47f-24bf-464a-aed7-54ad81abf121
                                                offset unit
                                                unicode_code_points
                                                source array index
                                                0
                                                source field
                                                indications_and_usage_exact
                                                source text sha256
                                                6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                                start
                                                153
                                              source span
                                              end
                                              1494
                                              end exclusive
                                              true
                                              exact text
                                              • have progressed following treatment or have no satisfactory alternative therapy.
                                              label id
                                              9fa5a47f-24bf-464a-aed7-54ad81abf121
                                              offset unit
                                              unicode_code_points
                                              source array index
                                              0
                                              source field
                                              indications_and_usage_exact
                                              source text sha256
                                              6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                              start
                                              1412
                                              source url
                                              https://api.fda.gov/drug/label.json?search=id%3A%229fa5a47f-24bf-464a-aed7-54ad81abf121%22
                                              spl effective date
                                              2024-06-13
                                              spl set id
                                              fb526827-40ba-4462-94cf-179ae3b0cb8a
                                              spl version
                                              6
                                              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
                                              unclear
                                              Passage 16 · approval contingency
                                              application numbers
                                              1. NDA218213
                                              brand names
                                              1. Augtyro
                                              classification reasons
                                              1. approval_contingency_words
                                              clinical review status
                                              pending
                                              content role
                                              approval_contingency
                                              context span
                                              end
                                              1778
                                              end exclusive
                                              true
                                              exact text
                                              1 )] , • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and • have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14.2 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
                                              label id
                                              9fa5a47f-24bf-464a-aed7-54ad81abf121
                                              offset unit
                                              unicode_code_points
                                              source array index
                                              0
                                              source field
                                              indications_and_usage_exact
                                              source text sha256
                                              6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                              start
                                              1295
                                              current approval status
                                              not_reconciled
                                              duplicate text group
                                              dup-3f65f268f39b956e6dd7
                                              extraction review status
                                              automated_candidate_pending_source_review
                                              generic names
                                              1. REPOTRECTINIB
                                              id
                                              ind-span-5c27fc0b422501a489fd
                                              label id
                                              9fa5a47f-24bf-464a-aed7-54ad81abf121
                                              positive predicate support span
                                              Source null
                                              qualifier mentions
                                                regulatory links
                                                  schema version
                                                  0.1.0
                                                  source batch sha256
                                                  424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                                                  source defined aliases
                                                  1. abbreviation
                                                    NSCLC
                                                    definition exact
                                                    non-small cell lung cancer
                                                    definition span
                                                    end
                                                    187
                                                    end exclusive
                                                    true
                                                    exact text
                                                    non-small cell lung cancer (NSCLC)
                                                    label id
                                                    9fa5a47f-24bf-464a-aed7-54ad81abf121
                                                    offset unit
                                                    unicode_code_points
                                                    source array index
                                                    0
                                                    source field
                                                    indications_and_usage_exact
                                                    source text sha256
                                                    6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                                    start
                                                    153
                                                  source span
                                                  end
                                                  1639
                                                  end exclusive
                                                  true
                                                  exact text
                                                  This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14.2 )] .
                                                  label id
                                                  9fa5a47f-24bf-464a-aed7-54ad81abf121
                                                  offset unit
                                                  unicode_code_points
                                                  source array index
                                                  0
                                                  source field
                                                  indications_and_usage_exact
                                                  source text sha256
                                                  6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                                  start
                                                  1495
                                                  source url
                                                  https://api.fda.gov/drug/label.json?search=id%3A%229fa5a47f-24bf-464a-aed7-54ad81abf121%22
                                                  spl effective date
                                                  2024-06-13
                                                  spl set id
                                                  fb526827-40ba-4462-94cf-179ae3b0cb8a
                                                  spl version
                                                  6
                                                  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
                                                  not_applicable
                                                  Passage 17 · approval contingency
                                                  application numbers
                                                  1. NDA218213
                                                  brand names
                                                  1. Augtyro
                                                  classification reasons
                                                  1. approval_contingency_words
                                                  clinical review status
                                                  pending
                                                  content role
                                                  approval_contingency
                                                  context span
                                                  end
                                                  1778
                                                  end exclusive
                                                  true
                                                  exact text
                                                  treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14.2 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
                                                  label id
                                                  9fa5a47f-24bf-464a-aed7-54ad81abf121
                                                  offset unit
                                                  unicode_code_points
                                                  source array index
                                                  0
                                                  source field
                                                  indications_and_usage_exact
                                                  source text sha256
                                                  6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                                  start
                                                  1440
                                                  current approval status
                                                  not_reconciled
                                                  duplicate text group
                                                  dup-003111ec8511cbac8409
                                                  extraction review status
                                                  automated_candidate_pending_source_review
                                                  generic names
                                                  1. REPOTRECTINIB
                                                  id
                                                  ind-span-a8be31806f67a772e5bf
                                                  label id
                                                  9fa5a47f-24bf-464a-aed7-54ad81abf121
                                                  positive predicate support span
                                                  Source null
                                                  qualifier mentions
                                                    regulatory links
                                                      schema version
                                                      0.1.0
                                                      source batch sha256
                                                      424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                                                      source defined aliases
                                                      1. abbreviation
                                                        NSCLC
                                                        definition exact
                                                        non-small cell lung cancer
                                                        definition span
                                                        end
                                                        187
                                                        end exclusive
                                                        true
                                                        exact text
                                                        non-small cell lung cancer (NSCLC)
                                                        label id
                                                        9fa5a47f-24bf-464a-aed7-54ad81abf121
                                                        offset unit
                                                        unicode_code_points
                                                        source array index
                                                        0
                                                        source field
                                                        indications_and_usage_exact
                                                        source text sha256
                                                        6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                                        start
                                                        153
                                                      source span
                                                      end
                                                      1778
                                                      end exclusive
                                                      true
                                                      exact text
                                                      Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
                                                      label id
                                                      9fa5a47f-24bf-464a-aed7-54ad81abf121
                                                      offset unit
                                                      unicode_code_points
                                                      source array index
                                                      0
                                                      source field
                                                      indications_and_usage_exact
                                                      source text sha256
                                                      6c5741a245ab41e6de4ae03b6405f170c4cc3855b8970d907915c8ccd5eae9e3
                                                      start
                                                      1640
                                                      source url
                                                      https://api.fda.gov/drug/label.json?search=id%3A%229fa5a47f-24bf-464a-aed7-54ad81abf121%22
                                                      spl effective date
                                                      2024-06-13
                                                      spl set id
                                                      fb526827-40ba-4462-94cf-179ae3b0cb8a
                                                      spl version
                                                      6
                                                      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
                                                      not_applicable

                                                      Preserved source evidence · Not medical advice