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LABELS · d4c7332d-4da7-4d70-8813-4cecd53fff2a

Inluriyo

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
2026-06-04
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE INLURIYO is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 ( ESR1 )-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. INLURIYO TM is an estrogen receptor antagonist indicated for: treatment of adults with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy ( 1 )
Full extracted label fields
application numbers
  1. NDA218881
boxed warning exact
    brand names
    1. Inluriyo
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5bc172e4-e8a2-441a-be52-279a7f890196
    generic names
    1. IMLUNESTRANT
    id
    d4c7332d-4da7-4d70-8813-4cecd53fff2a
    indications and usage exact
    1. 1 INDICATIONS AND USAGE INLURIYO is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 ( ESR1 )-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. INLURIYO TM is an estrogen receptor antagonist indicated for: treatment of adults with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Eli Lilly and Company
      matched search terms
      1. cancer
      package ndcs
      1. 0002-1717-28
      2. 0002-1717-56
      3. 0002-1717-61
      product ndcs
      1. 0002-1717
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 2725917
        2. 2725923
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00600.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
        600
        total
        830
        sha256
        a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
        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=600&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22d4c7332d-4da7-4d70-8813-4cecd53fff2a%22
        spl effective date
        2026-06-04
        spl effective time
        20260604
        spl set id
        5bc172e4-e8a2-441a-be52-279a7f890196
        spl version
        7
        substance names
        1. IMLUNESTRANT
        uniis
        1. 9CXQ3PF69U
        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
          NDA218881
          payload
          all indexed label documents
          1. Appl No
            218881
            Application Docs Date
            2025-09-26 00:00:00
            Application Docs ID
            83533
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          all submission records
          1. Appl No
            218881
            Review Priority
            STANDARD
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2025-09-25 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
          NDA218881
          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
          2025-09-25
          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
            218881
            Application Docs Date
            2025-09-26 00:00:00
            Application Docs ID
            83533
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          official application record
          Appl No
          218881
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          ELI LILLY AND CO
          openfda application present
          true
          products
          1. Active Ingredient
            IMLUNESTRANT TOSYLATE
            Appl No
            218881
            Drug Name
            INLURIYO
            Form
            TABLET;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. NDA218881
        brand names
        1. Inluriyo
        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
        518
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE INLURIYO is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 ( ESR1 )-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. INLURIYO TM is an estrogen receptor antagonist indicated for: treatment of adults with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer with disease progression followin
        label id
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        offset unit
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        source array index
        0
        source field
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        source text sha256
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        start
        0
        current approval status
        not_reconciled
        duplicate text group
        dup-7d65e40681290190fe73
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. IMLUNESTRANT
        id
        ind-span-137e1692e9d3eb80fd45
        label id
        d4c7332d-4da7-4d70-8813-4cecd53fff2a
        positive predicate support span
        end
        45
        end exclusive
        true
        exact text
        is indicated
        label id
        d4c7332d-4da7-4d70-8813-4cecd53fff2a
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
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        start
        33
        qualifier mentions
        1. context exact
          ATIONS AND USAGE INLURIYO is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growt
          kind
          age
          polarity
          not_inferred
          span
          end
          73
          end exclusive
          true
          exact text
          adults
          label id
          d4c7332d-4da7-4d70-8813-4cecd53fff2a
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          869fccc25333ee9fcc1d98e9b103a1b8a2e3e9dafe2c8fb9b4f426c7658e44ed
          start
          67
        2. context exact
          or (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 ( ESR1 )-mutated advanced or metastati
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          168
          end exclusive
          true
          exact text
          HER2)-negative
          label id
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          offset unit
          unicode_code_points
          source array index
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          source field
          indications_and_usage_exact
          source text sha256
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          start
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        3. context exact
          -negative, estrogen receptor-1 ( ESR1 )-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          262
          end exclusive
          true
          exact text
          metastatic breast cancer with disease progr
          label id
          d4c7332d-4da7-4d70-8813-4cecd53fff2a
          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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        4. context exact
          tor 2 (HER2)-negative, estrogen receptor-1 ( ESR1 )-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine
          kind
          stage_or_setting
          polarity
          not_inferred
          span
          end
          250
          end exclusive
          true
          exact text
          advanced or metastatic breast cancer with d
          label id
          d4c7332d-4da7-4d70-8813-4cecd53fff2a
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
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        regulatory links
          schema version
          0.1.0
          source batch sha256
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          source defined aliases
            source span
            end
            318
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE INLURIYO is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 ( ESR1 )-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
            label id
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            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            869fccc25333ee9fcc1d98e9b103a1b8a2e3e9dafe2c8fb9b4f426c7658e44ed
            start
            0
            source url
            https://api.fda.gov/drug/label.json?search=id%3A%22d4c7332d-4da7-4d70-8813-4cecd53fff2a%22
            spl effective date
            2026-06-04
            spl set id
            5bc172e4-e8a2-441a-be52-279a7f890196
            spl version
            7
            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. NDA218881
            brand names
            1. Inluriyo
            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
            564
            end exclusive
            true
            exact text
            pidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 ( ESR1 )-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. INLURIYO TM is an estrogen receptor antagonist indicated for: treatment of adults with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy ( 1 )
            label id
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            offset unit
            unicode_code_points
            source array index
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            source field
            indications_and_usage_exact
            source text sha256
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            start
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            current approval status
            not_reconciled
            duplicate text group
            dup-5ee30b8310e23b02e84f
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. IMLUNESTRANT
            id
            ind-span-2683631d5238c9dabf7c
            label id
            d4c7332d-4da7-4d70-8813-4cecd53fff2a
            positive predicate support span
            end
            375
            end exclusive
            true
            exact text
            is an estrogen receptor antagonist indicated
            label id
            d4c7332d-4da7-4d70-8813-4cecd53fff2a
            offset unit
            unicode_code_points
            source array index
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            source field
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            source text sha256
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            start
            331
            qualifier mentions
            1. context exact
              an estrogen receptor antagonist indicated for: treatment of adults with ER-positive, HER2-negative, ESR1 -mutated advanced or
              kind
              age
              polarity
              not_inferred
              span
              end
              400
              end exclusive
              true
              exact text
              adults
              label id
              d4c7332d-4da7-4d70-8813-4cecd53fff2a
              offset unit
              unicode_code_points
              source array index
              0
              source field
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              source text sha256
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            2. context exact
              gonist indicated for: treatment of adults with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer with di
              kind
              biomarker
              polarity
              not_inferred
              span
              end
              432
              end exclusive
              true
              exact text
              HER2-negative
              label id
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              offset unit
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              source field
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            3. context exact
              with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy ( 1
              kind
              biomarker
              polarity
              not_inferred
              span
              end
              503
              end exclusive
              true
              exact text
              metastatic breast cancer with disease progr
              label id
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              offset unit
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              source field
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              source text sha256
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              start
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            4. context exact
              nt of adults with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine
              kind
              stage_or_setting
              polarity
              not_inferred
              span
              end
              491
              end exclusive
              true
              exact text
              advanced or metastatic breast cancer with d
              label id
              d4c7332d-4da7-4d70-8813-4cecd53fff2a
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
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            regulatory links
              schema version
              0.1.0
              source batch sha256
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              source defined aliases
                source span
                end
                564
                end exclusive
                true
                exact text
                INLURIYO TM is an estrogen receptor antagonist indicated for: treatment of adults with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy ( 1 )
                label id
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                offset unit
                unicode_code_points
                source array index
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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%22d4c7332d-4da7-4d70-8813-4cecd53fff2a%22
                spl effective date
                2026-06-04
                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
                tumor_directed_candidate

                Preserved source evidence · Not medical advice