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LABELS · 040abaf0-7a15-11f1-b55a-0800200c9a66

ORSERDU

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
2026-06-24
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 ORSERDU is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)‑negative, ESR1 -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test [see Dosage and Administration ( 2.1 )] , with disease progression following at least one line of endocrine therapy. ORSERDU is an estrogen receptor antagonist indicated for: treatment of postmenopausal women or adult men, with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy ( 1 )
Full extracted label fields
application numbers
  1. NDA217639
boxed warning exact
    brand names
    1. ORSERDU
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aa66ae5c-2bd2-4444-8178-b55651e054ef
    generic names
    1. ELACESTRANT
    id
    040abaf0-7a15-11f1-b55a-0800200c9a66
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ORSERDU is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)‑negative, ESR1 -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test [see Dosage and Administration ( 2.1 )] , with disease progression following at least one line of endocrine therapy. ORSERDU is an estrogen receptor antagonist indicated for: treatment of postmenopausal women or adult men, with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, 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. Stemline Therapeutics, Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 72187-0101-3
      2. 72187-0102-3
      product ndcs
      1. 72187-0101
      2. 72187-0102
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 2628478
        2. 2628484
        3. 2628487
        4. 2628489
        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%22040abaf0-7a15-11f1-b55a-0800200c9a66%22
        spl effective date
        2026-06-24
        spl effective time
        20260624
        spl set id
        aa66ae5c-2bd2-4444-8178-b55651e054ef
        spl version
        9
        substance names
        1. ELACESTRANT
        uniis
        1. FM6A2627A8
        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
          NDA217639
          payload
          all indexed label documents
          1. Appl No
            217639
            Application Docs Date
            2026-02-24 00:00:00
            Application Docs ID
            76609
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            SUPPL
          2. Appl No
            217639
            Application Docs Date
            2026-02-24 00:00:00
            Application Docs ID
            85110
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          3. Appl No
            217639
            Application Docs Date
            2026-06-29 00:00:00
            Application Docs ID
            86381
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            7
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            217639
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            7
            Submission Status
            AP
            Submission Status Date
            2026-06-24 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            217639
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2023-11-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            217639
            Review Priority
            PRIORITY
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2023-01-27 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
          NDA217639
          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
          2026-06-24
          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
            217639
            Application Docs Date
            2026-06-29 00:00:00
            Application Docs ID
            86381
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            7
            Submission Type
            SUPPL
          official application record
          Appl No
          217639
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          STEMLINE THERAP
          openfda application present
          true
          products
          1. Active Ingredient
            ELACESTRANT HYDROCHLORIDE
            Appl No
            217639
            Drug Name
            ORSERDU
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            EQ 86MG BASE
            marketing status
            1. Prescription
          2. Active Ingredient
            ELACESTRANT HYDROCHLORIDE
            Appl No
            217639
            Drug Name
            ORSERDU
            Form
            TABLET;ORAL
            Product No
            002
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 345MG 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. NDA217639
        brand names
        1. ORSERDU
        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
        602
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE ORSERDU is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)‑negative, ESR1 -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test [see Dosage and Administration ( 2.1 )] , with disease progression following at least one line of endocrine therapy. ORSERDU is an estrogen receptor antagonist indicated for: treatment of postmenopausal women or adult men, with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer, as detec
        label id
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        unicode_code_points
        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
        dup-38f20ceb1f49eb538e1f
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. ELACESTRANT
        id
        ind-span-5d80705e3347867cdef8
        label id
        040abaf0-7a15-11f1-b55a-0800200c9a66
        positive predicate support span
        end
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        end exclusive
        true
        exact text
        is indicated
        label id
        040abaf0-7a15-11f1-b55a-0800200c9a66
        offset unit
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        source text sha256
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        start
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        qualifier mentions
        1. context exact
          U is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal g
          kind
          age
          polarity
          not_inferred
          span
          end
          95
          end exclusive
          true
          exact text
          adult
          label id
          040abaf0-7a15-11f1-b55a-0800200c9a66
          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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        2. context exact
          or (ER)-positive, human epidermal growth factor receptor 2 (HER2)‑negative, ESR1 -mutated advanced or metastatic breast cancer, as det
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          194
          end exclusive
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          exact text
          HER2)‑negative
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        3. context exact
          actor receptor 2 (HER2)‑negative, ESR1 -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test [see Dosage and Admi
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          246
          end exclusive
          true
          exact text
          metastatic breast cancer
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          0
          source field
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        4. context exact
          mal growth factor receptor 2 (HER2)‑negative, ESR1 -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test [see Dosage and Admi
          kind
          stage_or_setting
          polarity
          not_inferred
          span
          end
          246
          end exclusive
          true
          exact text
          advanced or metastatic breast cancer
          label id
          040abaf0-7a15-11f1-b55a-0800200c9a66
          offset unit
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          source field
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        regulatory links
          schema version
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          source batch sha256
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          source defined aliases
            source span
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            402
            end exclusive
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            exact text
            1 INDICATIONS AND USAGE ORSERDU is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)‑negative, ESR1 -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test [see Dosage and Administration ( 2.1 )] , with disease progression following at least one line of endocrine therapy.
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            offset unit
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            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%22040abaf0-7a15-11f1-b55a-0800200c9a66%22
            spl effective date
            2026-06-24
            spl set id
            aa66ae5c-2bd2-4444-8178-b55651e054ef
            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. NDA217639
            brand names
            1. ORSERDU
            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
            712
            end exclusive
            true
            exact text
            utated advanced or metastatic breast cancer, as detected by an FDA-authorized test [see Dosage and Administration ( 2.1 )] , with disease progression following at least one line of endocrine therapy. ORSERDU is an estrogen receptor antagonist indicated for: treatment of postmenopausal women or adult men, with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy ( 1 )
            label id
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            source text sha256
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            current approval status
            not_reconciled
            duplicate text group
            dup-80cd44e382129611e872
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. ELACESTRANT
            id
            ind-span-604eb320003dcb8f04f2
            label id
            040abaf0-7a15-11f1-b55a-0800200c9a66
            positive predicate support span
            end
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            end exclusive
            true
            exact text
            is an estrogen receptor antagonist indicated
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            qualifier mentions
            1. context exact
              agonist indicated for: treatment of postmenopausal women or adult men, with ER-positive, HER2-negative, ESR1 -mutated advance
              kind
              age
              polarity
              not_inferred
              span
              end
              503
              end exclusive
              true
              exact text
              adult
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            2. context exact
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              kind
              biomarker
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              not_inferred
              span
              end
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              end exclusive
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              exact text
              HER2-negative
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            3. context exact
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              kind
              biomarker
              polarity
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              span
              end
              592
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              metastatic breast cancer
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            4. context exact
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              kind
              stage_or_setting
              polarity
              not_inferred
              span
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              exact text
              advanced or metastatic breast cancer
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            regulatory links
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              source defined aliases
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                true
                exact text
                ORSERDU is an estrogen receptor antagonist indicated for: treatment of postmenopausal women or adult men, with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, 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%22040abaf0-7a15-11f1-b55a-0800200c9a66%22
                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
                tumor_directed_candidate

                Preserved source evidence · Not medical advice