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

LABELS · 6c672099-2978-474e-b783-973fe94efcfb

JIDEYTRO

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
2026-07-22
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE JIDEYTRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor [see Dosage and Administration ( 2.1 ), Clinical Studies ( 14.1 )] . JIDEYTRO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor.( 1 )
Full extracted label fields
application numbers
  1. NDA220185
boxed warning exact
    brand names
    1. JIDEYTRO
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3760e421-b523-4d9b-e063-6394a90ab94b
    generic names
    1. ZIDESAMTINIB
    id
    6c672099-2978-474e-b783-973fe94efcfb
    indications and usage exact
    1. 1 INDICATIONS AND USAGE JIDEYTRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor [see Dosage and Administration ( 2.1 ), Clinical Studies ( 14.1 )] . JIDEYTRO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor.( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Nuvalent, Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 85001-101-01
      2. 85001-102-01
      product ndcs
      1. 85001-101
      2. 85001-102
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 2748288
        2. 2748294
        3. 2748296
        4. 2748298
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00400.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
        400
        total
        830
        sha256
        a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
        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=400&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%226c672099-2978-474e-b783-973fe94efcfb%22
        spl effective date
        2026-07-22
        spl effective time
        20260722
        spl set id
        3760e421-b523-4d9b-e063-6394a90ab94b
        spl version
        5
        substance names
        1. ZIDESAMTINIB
        uniis
        1. MX5KQV5XHC
        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
        4. fda_label_posted_after_spl_effective_date_requires_version_review
        Drugs@FDA application source records
        1. application number
          NDA220185
          payload
          all indexed label documents
          1. Appl No
            220185
            Application Docs Date
            2026-07-27 00:00:00
            Application Docs ID
            86712
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          all submission records
          1. Appl No
            220185
            Review Priority
            STANDARD
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2026-07-22 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
          NDA220185
          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
          2026-07-22
          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
            220185
            Application Docs Date
            2026-07-27 00:00:00
            Application Docs ID
            86712
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          official application record
          Appl No
          220185
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          NUVALENT
          openfda application present
          true
          products
          1. Active Ingredient
            ZIDESAMTINIB
            Appl No
            220185
            Drug Name
            JIDEYTRO
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            25MG
            marketing status
            1. Prescription
          2. Active Ingredient
            ZIDESAMTINIB
            Appl No
            220185
            Drug Name
            JIDEYTRO
            Form
            TABLET;ORAL
            Product No
            002
            Reference Drug
            1
            Reference Standard
            1
            Strength
            100MG
            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. NDA220185
        brand names
        1. JIDEYTRO
        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
        479
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE JIDEYTRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor [see Dosage and Administration ( 2.1 ), Clinical Studies ( 14.1 )] . JIDEYTRO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inh
        label id
        6c672099-2978-474e-b783-973fe94efcfb
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        1f23abdb3f610bb84192c5c292e24e932f0d7eb7a3ce0cdf2373009780e2558a
        start
        0
        current approval status
        not_reconciled
        duplicate text group
        dup-06c044b5c9cbb1403ff7
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. ZIDESAMTINIB
        id
        ind-span-8a1448085989e4557424
        label id
        6c672099-2978-474e-b783-973fe94efcfb
        positive predicate support span
        end
        45
        end exclusive
        true
        exact text
        is indicated
        label id
        6c672099-2978-474e-b783-973fe94efcfb
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        1f23abdb3f610bb84192c5c292e24e932f0d7eb7a3ce0cdf2373009780e2558a
        start
        33
        qualifier mentions
        1. context exact
          ATIONS AND USAGE JIDEYTRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-smal
          kind
          age
          polarity
          not_inferred
          span
          end
          81
          end exclusive
          true
          exact text
          adult patients
          label id
          6c672099-2978-474e-b783-973fe94efcfb
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          1f23abdb3f610bb84192c5c292e24e932f0d7eb7a3ce0cdf2373009780e2558a
          start
          67
        2. context exact
          or the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          150
          end exclusive
          true
          exact text
          metastatic ROS1 -positive non-small cell lu
          label id
          6c672099-2978-474e-b783-973fe94efcfb
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          1f23abdb3f610bb84192c5c292e24e932f0d7eb7a3ce0cdf2373009780e2558a
          start
          107
        3. context exact
          ive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor [see Dosage and Administration ( 2.1 ), Clinical Studies ( 14.1 )] .
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          233
          end exclusive
          true
          exact text
          ROS1 kinase inhibitor [see Dosage and Admini
          label id
          6c672099-2978-474e-b783-973fe94efcfb
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          1f23abdb3f610bb84192c5c292e24e932f0d7eb7a3ce0cdf2373009780e2558a
          start
          189
        4. context exact
          EYTRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kina
          kind
          stage_or_setting
          polarity
          not_inferred
          span
          end
          138
          end exclusive
          true
          exact text
          locally advanced or metastatic ROS1 -positive non-s
          label id
          6c672099-2978-474e-b783-973fe94efcfb
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          1f23abdb3f610bb84192c5c292e24e932f0d7eb7a3ce0cdf2373009780e2558a
          start
          87
        regulatory links
          schema version
          0.1.0
          source batch sha256
          a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
          source defined aliases
          1. abbreviation
            NSCLC
            definition exact
            non-small cell lung cancer
            definition span
            end
            167
            end exclusive
            true
            exact text
            non-small cell lung cancer (NSCLC)
            label id
            6c672099-2978-474e-b783-973fe94efcfb
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            1f23abdb3f610bb84192c5c292e24e932f0d7eb7a3ce0cdf2373009780e2558a
            start
            133
          source span
          end
          279
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE JIDEYTRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor [see Dosage and Administration ( 2.1 ), Clinical Studies ( 14.1 )] .
          label id
          6c672099-2978-474e-b783-973fe94efcfb
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          1f23abdb3f610bb84192c5c292e24e932f0d7eb7a3ce0cdf2373009780e2558a
          start
          0
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%226c672099-2978-474e-b783-973fe94efcfb%22
          spl effective date
          2026-07-22
          spl set id
          3760e421-b523-4d9b-e063-6394a90ab94b
          spl version
          5
          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. NDA220185
          brand names
          1. JIDEYTRO
          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
          491
          end exclusive
          true
          exact text
          s with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor [see Dosage and Administration ( 2.1 ), Clinical Studies ( 14.1 )] . JIDEYTRO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor.( 1 )
          label id
          6c672099-2978-474e-b783-973fe94efcfb
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          1f23abdb3f610bb84192c5c292e24e932f0d7eb7a3ce0cdf2373009780e2558a
          start
          80
          current approval status
          not_reconciled
          duplicate text group
          dup-a58ea754114be9c07ee6
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. ZIDESAMTINIB
          id
          ind-span-d2b34f0a1e57e556ebd0
          label id
          6c672099-2978-474e-b783-973fe94efcfb
          positive predicate support span
          end
          320
          end exclusive
          true
          exact text
          is a kinase inhibitor indicated
          label id
          6c672099-2978-474e-b783-973fe94efcfb
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          1f23abdb3f610bb84192c5c292e24e932f0d7eb7a3ce0cdf2373009780e2558a
          start
          289
          qualifier mentions
          1. context exact
            DEYTRO 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
            356
            end exclusive
            true
            exact text
            adult patients
            label id
            6c672099-2978-474e-b783-973fe94efcfb
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            1f23abdb3f610bb84192c5c292e24e932f0d7eb7a3ce0cdf2373009780e2558a
            start
            342
          2. context exact
            or the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            425
            end exclusive
            true
            exact text
            metastatic ROS1 -positive non-small cell lu
            label id
            6c672099-2978-474e-b783-973fe94efcfb
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            1f23abdb3f610bb84192c5c292e24e932f0d7eb7a3ce0cdf2373009780e2558a
            start
            382
          3. context exact
            ive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor.( 1 )
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            485
            end exclusive
            true
            exact text
            ROS1 kinase inhibitor
            label id
            6c672099-2978-474e-b783-973fe94efcfb
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            1f23abdb3f610bb84192c5c292e24e932f0d7eb7a3ce0cdf2373009780e2558a
            start
            464
          4. context exact
            nhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kina
            kind
            stage_or_setting
            polarity
            not_inferred
            span
            end
            413
            end exclusive
            true
            exact text
            locally advanced or metastatic ROS1 -positive non-s
            label id
            6c672099-2978-474e-b783-973fe94efcfb
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            1f23abdb3f610bb84192c5c292e24e932f0d7eb7a3ce0cdf2373009780e2558a
            start
            362
          regulatory links
            schema version
            0.1.0
            source batch sha256
            a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
            source defined aliases
            1. abbreviation
              NSCLC
              definition exact
              non-small cell lung cancer
              definition span
              end
              167
              end exclusive
              true
              exact text
              non-small cell lung cancer (NSCLC)
              label id
              6c672099-2978-474e-b783-973fe94efcfb
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              1f23abdb3f610bb84192c5c292e24e932f0d7eb7a3ce0cdf2373009780e2558a
              start
              133
            source span
            end
            491
            end exclusive
            true
            exact text
            JIDEYTRO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor.( 1 )
            label id
            6c672099-2978-474e-b783-973fe94efcfb
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            1f23abdb3f610bb84192c5c292e24e932f0d7eb7a3ce0cdf2373009780e2558a
            start
            280
            source url
            https://api.fda.gov/drug/label.json?search=id%3A%226c672099-2978-474e-b783-973fe94efcfb%22
            spl effective date
            2026-07-22
            spl set id
            3760e421-b523-4d9b-e063-6394a90ab94b
            spl version
            5
            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

            Preserved source evidence · Not medical advice