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LABELS · 5154bda7-7ab4-4ad4-8fee-7fbe9ea692cc

IBTROZI

Open original source → · Download preserved record

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

Label effective date
2026-03-23
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE IBTROZI ® (taletrectinib) 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 )] . IBTROZI 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 )
Full extracted label fields
application numbers
  1. NDA219713
boxed warning exact
    brand names
    1. IBTROZI
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51ac8e52-3269-4102-8dc8-dba22d82128c
    generic names
    1. TALETRECTINIB
    id
    5154bda7-7ab4-4ad4-8fee-7fbe9ea692cc
    indications and usage exact
    1. 1 INDICATIONS AND USAGE IBTROZI ® (taletrectinib) 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 )] . IBTROZI 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 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Nuvation Bio Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 84651-200-30
      2. 84651-200-93
      3. 84651-200-90
      product ndcs
      1. 84651-200
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 2716925
        2. 2716931
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00300.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
        300
        total
        830
        sha256
        bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
        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=300&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%225154bda7-7ab4-4ad4-8fee-7fbe9ea692cc%22
        spl effective date
        2026-03-23
        spl effective time
        20260323
        spl set id
        51ac8e52-3269-4102-8dc8-dba22d82128c
        spl version
        4
        substance names
        1. TALETRECTINIB ADIPATE
        uniis
        1. 6KLL51GNBG
        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
          NDA219713
          payload
          all indexed label documents
          1. Appl No
            219713
            Application Docs Date
            2025-06-12 00:00:00
            Application Docs ID
            82557
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          all submission records
          1. Appl No
            219713
            Review Priority
            PRIORITY
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2025-06-11 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
          NDA219713
          approval interpretation
          Application linkage and approved submission are not indication-level current approval verification
          current indication status
          not_reconciled
          has approved submission record
          true
          latest approved submission date
          2025-06-11
          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
            219713
            Application Docs Date
            2025-06-12 00:00:00
            Application Docs ID
            82557
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          official application record
          Appl No
          219713
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          NUVATION
          openfda application present
          true
          products
          1. Active Ingredient
            TALETRECTINIB ADIPATE
            Appl No
            219713
            Drug Name
            IBTROZI
            Form
            CAPSULE;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 200MG BASE
            marketing status
            1. Prescription

        Source passages and status connections

        Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

        Passage 1 · positive indication candidate
        application numbers
        1. NDA219713
        brand names
        1. IBTROZI
        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
        395
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE IBTROZI ® (taletrectinib) 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 )] . IBTROZI 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 )
        label id
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        offset unit
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        source text sha256
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        current approval status
        not_reconciled
        duplicate text group
        dup-2d93c4f34fcc564e5ddd
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. TALETRECTINIB
        id
        ind-span-584663b07e75c51c0246
        label id
        5154bda7-7ab4-4ad4-8fee-7fbe9ea692cc
        positive predicate support span
        end
        62
        end exclusive
        true
        exact text
        is indicated
        label id
        5154bda7-7ab4-4ad4-8fee-7fbe9ea692cc
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
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        start
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        qualifier mentions
        1. context exact
          IBTROZI ® (taletrectinib) is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-smal
          kind
          age
          polarity
          not_inferred
          span
          end
          98
          end exclusive
          true
          exact text
          adult patients
          label id
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          offset unit
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          source text sha256
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        2. 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
          167
          end exclusive
          true
          exact text
          metastatic ROS1 -positive non-small cell lu
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          source text sha256
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        3. context exact
          inib) 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
          155
          end exclusive
          true
          exact text
          locally advanced or metastatic ROS1 -positive non-s
          label id
          5154bda7-7ab4-4ad4-8fee-7fbe9ea692cc
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        regulatory links
          schema version
          0.1.0
          source batch sha256
          bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
          source defined aliases
          1. abbreviation
            NSCLC
            definition exact
            non-small cell lung cancer
            definition span
            end
            184
            end exclusive
            true
            exact text
            non-small cell lung cancer (NSCLC)
            label id
            5154bda7-7ab4-4ad4-8fee-7fbe9ea692cc
            offset unit
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          source span
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          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE IBTROZI ® (taletrectinib) 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
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          source field
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          source text sha256
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          start
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          source url
          https://api.fda.gov/drug/label.json?search=id%3A%225154bda7-7ab4-4ad4-8fee-7fbe9ea692cc%22
          spl effective date
          2026-03-23
          spl set id
          51ac8e52-3269-4102-8dc8-dba22d82128c
          spl version
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          structured fields status
          not_extracted_no_values_inferred_from_mentions
          structured indication
          age
          Source null
          approval pathway
          Source null
          biomarker and test
          Source null
          disease stage
          Source null
          limitations
          Source null
          line
          Source null
          prior therapy
          Source null
          regimen
          Source null
          tumor histology
          Source null
          use intent
          tumor_directed_candidate
          Passage 2 · positive indication candidate
          application numbers
          1. NDA219713
          brand names
          1. IBTROZI
          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
          395
          end exclusive
          true
          exact text
          ROZI ® (taletrectinib) 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 )] . IBTROZI 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 )
          label id
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          offset unit
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          source field
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          source text sha256
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          current approval status
          not_reconciled
          duplicate text group
          dup-3a3f2cdd8a0b9f704580
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. TALETRECTINIB
          id
          ind-span-6bbfdff4f4df9bc7eef3
          label id
          5154bda7-7ab4-4ad4-8fee-7fbe9ea692cc
          positive predicate support span
          end
          266
          end exclusive
          true
          exact text
          is a kinase inhibitor indicated
          label id
          5154bda7-7ab4-4ad4-8fee-7fbe9ea692cc
          offset unit
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          source array index
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          source field
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          source text sha256
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          qualifier mentions
          1. context exact
            BTROZI is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-smal
            kind
            age
            polarity
            not_inferred
            span
            end
            302
            end exclusive
            true
            exact text
            adult patients
            label id
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            offset unit
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            source array index
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          2. context exact
            or the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC).
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            371
            end exclusive
            true
            exact text
            metastatic ROS1 -positive non-small cell lu
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          3. context exact
            nhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC).
            kind
            stage_or_setting
            polarity
            not_inferred
            span
            end
            359
            end exclusive
            true
            exact text
            locally advanced or metastatic ROS1 -positive non-s
            label id
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          regulatory links
            schema version
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            source batch sha256
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            source defined aliases
            1. abbreviation
              NSCLC
              definition exact
              non-small cell lung cancer
              definition span
              end
              184
              end exclusive
              true
              exact text
              non-small cell lung cancer (NSCLC)
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            source span
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            end exclusive
            true
            exact text
            IBTROZI is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC).
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            source url
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            spl effective date
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            spl set id
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            structured fields status
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            structured indication
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            Source null
            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 3 · unclassified context
            application numbers
            1. NDA219713
            brand names
            1. IBTROZI
            classification reasons
            1. no_unambiguous_positive_indication_predicate
            clinical review status
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            content role
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            context span
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            395
            end exclusive
            true
            exact text
            Dosage and Administration ( 2.1 )] . IBTROZI 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 )
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            current approval status
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            positive predicate support span
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            qualifier mentions
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                exact text
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                offset unit
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                source url
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                spl effective date
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                spl set id
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                spl version
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                structured fields status
                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

                Preserved source evidence · Not medical advice