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LABELS · 35775ae7-f00d-1c21-e063-6294a90a914c

VEPPANU

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
2025-05-01
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE VEPPANU 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, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. VEPPANU is a heterobifunctional protein degrader 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, 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. NDA219835
boxed warning exact
    brand names
    1. VEPPANU
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=751e18d5-1d41-4b67-b1f3-10272ca5312d
    generic names
    1. VEPDEGESTRANT
    id
    35775ae7-f00d-1c21-e063-6294a90a914c
    indications and usage exact
    1. 1 INDICATIONS AND USAGE VEPPANU 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, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. VEPPANU is a heterobifunctional protein degrader 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, 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. Arvinas Operations, Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 84043-100-30
      2. 84043-200-30
      product ndcs
      1. 84043-100
      2. 84043-200
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 2743355
        2. 2743361
        3. 2743363
        4. 2743365
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00100.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
        100
        total
        830
        sha256
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        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=100&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%2235775ae7-f00d-1c21-e063-6294a90a914c%22
        spl effective date
        2025-05-01
        spl effective time
        20250501
        spl set id
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        spl version
        2
        substance names
        1. VEPDEGESTRANT
        uniis
        1. WC1U3R1YMI
        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
          NDA219835
          payload
          all indexed label documents
          1. Appl No
            219835
            Application Docs Date
            2026-06-01 00:00:00
            Application Docs ID
            86101
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          all submission records
          1. Appl No
            219835
            Review Priority
            STANDARD
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2026-05-01 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
          NDA219835
          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
          2026-05-01
          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
            219835
            Application Docs Date
            2026-06-01 00:00:00
            Application Docs ID
            86101
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          official application record
          Appl No
          219835
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          RIGEL PHARMS
          openfda application present
          true
          products
          1. Active Ingredient
            VEPDEGESTRANT
            Appl No
            219835
            Drug Name
            VEPPANU
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            100MG
            marketing status
            1. Prescription
          2. Active Ingredient
            VEPDEGESTRANT
            Appl No
            219835
            Drug Name
            VEPPANU
            Form
            TABLET;ORAL
            Product No
            002
            Reference Drug
            1
            Reference Standard
            1
            Strength
            200MG
            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. NDA219835
        brand names
        1. VEPPANU
        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
        556
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE VEPPANU 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, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. VEPPANU is a heterobifunctional protein degrader indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen recepto
        label id
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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
        automated_candidate_pending_source_review
        generic names
        1. VEPDEGESTRANT
        id
        ind-span-c6a4ee9d0916cdc06d6a
        label id
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        positive predicate support span
        end
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        end exclusive
        true
        exact text
        is indicated
        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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        qualifier mentions
        1. context exact
          CATIONS AND USAGE VEPPANU is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growt
          kind
          age
          polarity
          not_inferred
          span
          end
          72
          end exclusive
          true
          exact text
          adults
          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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        2. context exact
          or (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1) -mutated advanced or metastatic
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          167
          end exclusive
          true
          exact text
          HER2)-negative
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        3. context exact
          )-negative, estrogen receptor-1 (ESR1) -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progre
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          end exclusive
          true
          exact text
          metastatic breast cancer
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        4. context exact
          ptor 2 (HER2)-negative, estrogen receptor-1 (ESR1) -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progre
          kind
          stage_or_setting
          polarity
          not_inferred
          span
          end
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          end exclusive
          true
          exact text
          advanced or metastatic breast cancer
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        regulatory links
          schema version
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          source defined aliases
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            exact text
            1 INDICATIONS AND USAGE VEPPANU 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, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
            label id
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            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%2235775ae7-f00d-1c21-e063-6294a90a914c%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
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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 2 · positive indication candidate
            application numbers
            1. NDA219835
            brand names
            1. VEPPANU
            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
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            734
            end exclusive
            true
            exact text
            )-negative, estrogen receptor-1 (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. VEPPANU is a heterobifunctional protein degrader 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, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. ( 1 )
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            current approval status
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            duplicate text group
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            extraction review status
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            generic names
            1. VEPDEGESTRANT
            id
            ind-span-5939e3639a3a5a60083f
            label id
            35775ae7-f00d-1c21-e063-6294a90a914c
            positive predicate support span
            end
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            end exclusive
            true
            exact text
            is a heterobifunctional protein degrader indicated
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            qualifier mentions
            1. context exact
              ifunctional protein degrader indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growt
              kind
              age
              polarity
              not_inferred
              span
              end
              443
              end exclusive
              true
              exact text
              adults
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            2. context exact
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              HER2)-negative
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              exact text
              metastatic breast cancer
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            4. context exact
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              stage_or_setting
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            regulatory links
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                exact text
                VEPPANU is a heterobifunctional protein degrader 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, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
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                source url
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                prior therapy
                Source null
                regimen
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                tumor histology
                Source null
                use intent
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                Passage 3 · unclassified context
                application numbers
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                exact text
                -negative, estrogen receptor-1 ( 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 )
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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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                      biomarker and test
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                      disease stage
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                      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