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LABELS · 17196ce1-224e-4359-ac54-39e035def74f

ENSACOVE

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
2026-02-17
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ENSACOVE is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)as detected by an FDA-approved test [see Dosage and Administration ( 2.1 )] who have not previously received an ALK-inhibitor. ENSACOVE is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test who have not previously received an ALK-inhibitor. ( 1 , 2.1 )
Full extracted label fields
application numbers
  1. NDA218171
boxed warning exact
    brand names
    1. ENSACOVE
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e1b2f79-678a-472a-b924-66909c8a4b2e
    generic names
    1. ENSARTINIB
    id
    17196ce1-224e-4359-ac54-39e035def74f
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ENSACOVE is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)as detected by an FDA-approved test [see Dosage and Administration ( 2.1 )] who have not previously received an ALK-inhibitor. ENSACOVE is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test who have not previously received an ALK-inhibitor. ( 1 , 2.1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Xcovery Holdings, Inc.
      matched search terms
      1. cancer
      2. lymphoma
      package ndcs
      1. 83076-1025-3
      2. 83076-1100-6
      product ndcs
      1. 83076-1025
      2. 83076-1100
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 2712634
        2. 2712640
        3. 2712642
        4. 2712644
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00000.json
        meta
        disclaimer
        Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
        last updated
        2026-09-09
        results
        limit
        100
        skip
        0
        total
        830
        sha256
        0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
        url
        https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=0&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%2217196ce1-224e-4359-ac54-39e035def74f%22
        spl effective date
        2026-02-17
        spl effective time
        20260217
        spl set id
        1e1b2f79-678a-472a-b924-66909c8a4b2e
        spl version
        5
        substance names
        1. ENSARTINIB HYDROCHLORIDE
        uniis
        1. C2FR6VT1BQ
        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
          NDA218171
          payload
          all indexed label documents
          1. Appl No
            218171
            Application Docs Date
            2024-12-19 00:00:00
            Application Docs ID
            80629
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            218171
            Application Docs Date
            2026-01-12 00:00:00
            Application Docs ID
            84734
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            SUPPL
          3. Appl No
            218171
            Application Docs Date
            2026-03-02 00:00:00
            Application Docs ID
            85192
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            3
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            218171
            Review Priority
            STANDARD
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2024-12-18 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            218171
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2026-01-08 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            218171
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            3
            Submission Status
            AP
            Submission Status Date
            2026-02-26 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA218171
          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
          2026-02-26
          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
            218171
            Application Docs Date
            2026-03-02 00:00:00
            Application Docs ID
            85192
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            3
            Submission Type
            SUPPL
          official application record
          Appl No
          218171
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          XCOVERY
          openfda application present
          true
          products
          1. Active Ingredient
            ENSARTINIB HYDROCHLORIDE
            Appl No
            218171
            Drug Name
            ENSACOVE
            Form
            CAPSULE;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            EQ 25MG BASE
            marketing status
            1. Prescription
          2. Active Ingredient
            ENSARTINIB HYDROCHLORIDE
            Appl No
            218171
            Drug Name
            ENSACOVE
            Form
            CAPSULE;ORAL
            Product No
            002
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 100MG 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. NDA218171
        brand names
        1. ENSACOVE
        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
        520
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE ENSACOVE is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)as detected by an FDA-approved test [see Dosage and Administration ( 2.1 )] who have not previously received an ALK-inhibitor. ENSACOVE is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) as detect
        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-7729f451342aa9e4c8e7
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. ENSARTINIB
        id
        ind-span-e81da165ceff3c91c928
        label id
        17196ce1-224e-4359-ac54-39e035def74f
        positive predicate support span
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        end exclusive
        true
        exact text
        is indicated
        label id
        17196ce1-224e-4359-ac54-39e035def74f
        offset unit
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        0
        source field
        indications_and_usage_exact
        source text sha256
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        qualifier mentions
        1. context exact
          ATIONS AND USAGE ENSACOVE is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally adva
          kind
          age
          polarity
          not_inferred
          span
          end
          81
          end exclusive
          true
          exact text
          adult patients
          label id
          17196ce1-224e-4359-ac54-39e035def74f
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          source text sha256
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        2. context exact
          reatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)as detected by an FDA-ap
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          158
          end exclusive
          true
          exact text
          ALK)-positive locally advanced or metastati
          label id
          17196ce1-224e-4359-ac54-39e035def74f
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          source field
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          source text sha256
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        3. context exact
          Administration ( 2.1 )] who have not previously received an ALK-inhibitor.
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          319
          end exclusive
          true
          exact text
          ALK-inhibitor
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        4. context exact
          ult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)as detected by an FDA-approved test [see Dosag
          kind
          stage_or_setting
          polarity
          not_inferred
          span
          end
          180
          end exclusive
          true
          exact text
          locally advanced or metastatic non-small cell lung
          label id
          17196ce1-224e-4359-ac54-39e035def74f
          offset unit
          unicode_code_points
          source array index
          0
          source field
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          source text sha256
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        regulatory links
          schema version
          0.1.0
          source batch sha256
          0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
          source defined aliases
          1. abbreviation
            NSCLC
            definition exact
            non-small cell lung cancer
            definition span
            end
            194
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            true
            exact text
            non-small cell lung cancer (NSCLC)
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          source span
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          exact text
          1 INDICATIONS AND USAGE ENSACOVE is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)as detected by an FDA-approved test [see Dosage and Administration ( 2.1 )] who have not previously received an ALK-inhibitor.
          label id
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          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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          source url
          https://api.fda.gov/drug/label.json?search=id%3A%2217196ce1-224e-4359-ac54-39e035def74f%22
          spl effective date
          2026-02-17
          spl set id
          1e1b2f79-678a-472a-b924-66909c8a4b2e
          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. NDA218171
          brand names
          1. ENSACOVE
          classification reasons
          1. explicit_positive_indication_predicate
          2. tumor_or_malignant_hematology_words_in_positive_statement
          clinical review status
          pending
          content role
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          609
          end exclusive
          true
          exact text
          ositive locally advanced or metastatic non-small cell lung cancer (NSCLC)as detected by an FDA-approved test [see Dosage and Administration ( 2.1 )] who have not previously received an ALK-inhibitor. ENSACOVE is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test who have not previously received an ALK-inhibitor. ( 1 , 2.1 )
          label id
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          offset unit
          unicode_code_points
          source array index
          0
          source field
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          source text sha256
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          current approval status
          not_reconciled
          duplicate text group
          dup-4fa796a2b3946aa7fcd9
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. ENSARTINIB
          id
          ind-span-1ac1d672d213cabe004b
          label id
          17196ce1-224e-4359-ac54-39e035def74f
          positive predicate support span
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          end exclusive
          true
          exact text
          is a kinase inhibitor indicated
          label id
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          qualifier mentions
          1. context exact
            SACOVE is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally adva
            kind
            age
            polarity
            not_inferred
            span
            end
            397
            end exclusive
            true
            exact text
            adult patients
            label id
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          2. context exact
            reatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-a
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            474
            end exclusive
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            exact text
            ALK)-positive locally advanced or metastati
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          3. context exact
            by an FDA-approved test who have not previously received an ALK-inhibitor.
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            ALK-inhibitor
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          4. context exact
            ult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test who have
            kind
            stage_or_setting
            polarity
            not_inferred
            span
            end
            496
            end exclusive
            true
            exact text
            locally advanced or metastatic non-small cell lung
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          regulatory links
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              definition exact
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              end exclusive
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            source span
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            exact text
            ENSACOVE is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test who have not previously received an ALK-inhibitor.
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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
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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. NDA218171
            brand names
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            classification reasons
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            clinical review status
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            content role
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            end exclusive
            true
            exact text
            with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test who have not previously received an ALK-inhibitor. ( 1 , 2.1 )
            label id
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            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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            current approval status
            not_reconciled
            duplicate text group
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            extraction review status
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            generic names
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            id
            ind-span-933ee27608e4d6ca38fe
            label id
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            positive predicate support span
            Source null
            qualifier mentions
              regulatory links
                schema version
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                source batch sha256
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                source defined aliases
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                  definition exact
                  non-small cell lung cancer
                  definition span
                  end
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                  end exclusive
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                  exact text
                  non-small cell lung cancer (NSCLC)
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                  offset unit
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                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  051c8bdc1d65e92b77a1d82a4728773b99bac0f16f42441141c9a211bdcbf111
                  start
                  160
                source span
                end
                609
                end exclusive
                true
                exact text
                ( 1 , 2.1 )
                label id
                17196ce1-224e-4359-ac54-39e035def74f
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                051c8bdc1d65e92b77a1d82a4728773b99bac0f16f42441141c9a211bdcbf111
                start
                598
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%2217196ce1-224e-4359-ac54-39e035def74f%22
                spl effective date
                2026-02-17
                spl set id
                1e1b2f79-678a-472a-b924-66909c8a4b2e
                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
                unclear

                Preserved source evidence · Not medical advice