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LABELS · a20856d6-9ddc-4e6a-bd63-d19cdcec6a41

OGSIVEO

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
2026-09-01
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE OGSIVEO is indicated for adult patients with progressing desmoid tumors who require systemic treatment. OGSIVEO is a gamma secretase inhibitor indicated for adult patients with progressing desmoid tumors who require systemic treatment. ( 1 )
Full extracted label fields
application numbers
  1. NDA217677
boxed warning exact
    brand names
    1. OGSIVEO
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f172e6ff-3190-41b0-b95a-58a7ef9e9e1e
    generic names
    1. NIROGACESTAT
    id
    a20856d6-9ddc-4e6a-bd63-d19cdcec6a41
    indications and usage exact
    1. 1 INDICATIONS AND USAGE OGSIVEO is indicated for adult patients with progressing desmoid tumors who require systemic treatment. OGSIVEO is a gamma secretase inhibitor indicated for adult patients with progressing desmoid tumors who require systemic treatment. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. SpringWorks Therapeutics, Inc.
      matched search terms
      1. tumors
      2. desmoid
      package ndcs
      1. 82448-100-14
      2. 82448-150-14
      product ndcs
      1. 82448-100
      2. 82448-150
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions ( 5.6 ) 08/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00500.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
        500
        total
        830
        sha256
        424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
        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=500&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22a20856d6-9ddc-4e6a-bd63-d19cdcec6a41%22
        spl effective date
        2026-09-01
        spl effective time
        20260901
        spl set id
        f172e6ff-3190-41b0-b95a-58a7ef9e9e1e
        spl version
        16
        substance names
        1. NIROGACESTAT
        uniis
        1. QZ62892OFJ
        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
          NDA217677
          payload
          all indexed label documents
          1. Appl No
            217677
            Application Docs Date
            2023-12-15 00:00:00
            Application Docs ID
            76667
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            217677
            Application Docs Date
            2024-04-25 00:00:00
            Application Docs ID
            78248
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            SUPPL
          3. Appl No
            217677
            Application Docs Date
            2026-03-12 00:00:00
            Application Docs ID
            85361
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            6
            Submission Type
            SUPPL
          4. Appl No
            217677
            Application Docs Date
            2026-07-21 00:00:00
            Application Docs ID
            86624
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            8
            Submission Type
            SUPPL
          5. Appl No
            217677
            Application Docs Date
            2026-08-25 00:00:00
            Application Docs ID
            87025
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            217677
            Review Priority
            PRIORITY
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2023-11-27 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            217677
            Review Priority
            N/A
            Submission Class Code ID
            4
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2024-04-04 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            217677
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            6
            Submission Status
            AP
            Submission Status Date
            2026-03-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            217677
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            8
            Submission Status
            AP
            Submission Status Date
            2026-07-17 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            217677
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            9
            Submission Status
            AP
            Submission Status Date
            2026-08-20 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA217677
          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
          2026-08-20
          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
            217677
            Application Docs Date
            2026-08-25 00:00:00
            Application Docs ID
            87025
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          official application record
          Appl No
          217677
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          SPRINGWORKS
          openfda application present
          true
          products
          1. Active Ingredient
            NIROGACESTAT HYDROBROMIDE
            Appl No
            217677
            Drug Name
            OGSIVEO
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            EQ 50MG BASE
            marketing status
            1. Discontinued
          2. Active Ingredient
            NIROGACESTAT HYDROBROMIDE
            Appl No
            217677
            Drug Name
            OGSIVEO
            Form
            TABLET;ORAL
            Product No
            002
            Reference Drug
            1
            Reference Standard
            0
            Strength
            EQ 100MG BASE
            marketing status
            1. Prescription
          3. Active Ingredient
            NIROGACESTAT HYDROBROMIDE
            Appl No
            217677
            Drug Name
            OGSIVEO
            Form
            TABLET;ORAL
            Product No
            003
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 150MG 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. NDA217677
        brand names
        1. OGSIVEO
        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
        265
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE OGSIVEO is indicated for adult patients with progressing desmoid tumors who require systemic treatment. OGSIVEO is a gamma secretase inhibitor indicated for adult patients with progressing desmoid tumors who require systemic treatment. ( 1 )
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        duplicate text group
        dup-df572099b2d5614db294
        extraction review status
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        generic names
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        id
        ind-span-112c8461149db6d17fba
        label id
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        positive predicate support span
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        end exclusive
        true
        exact text
        is indicated
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        start
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        qualifier mentions
        1. context exact
          1 INDICATIONS AND USAGE OGSIVEO is indicated for adult patients with progressing desmoid tumors who require systemic treatm
          kind
          age
          polarity
          not_inferred
          span
          end
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          exact text
          adult patients
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          start
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        regulatory links
          schema version
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            exact text
            1 INDICATIONS AND USAGE OGSIVEO is indicated for adult patients with progressing desmoid tumors who require systemic treatment.
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            start
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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
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            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. NDA217677
            brand names
            1. OGSIVEO
            classification reasons
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            2. tumor_or_malignant_hematology_words_in_positive_statement
            clinical review status
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            true
            exact text
            1 INDICATIONS AND USAGE OGSIVEO is indicated for adult patients with progressing desmoid tumors who require systemic treatment. OGSIVEO is a gamma secretase inhibitor indicated for adult patients with progressing desmoid tumors who require systemic treatment. ( 1 )
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            label id
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            exact text
            is a gamma secretase inhibitor indicated
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            qualifier mentions
            1. context exact
              OGSIVEO is a gamma secretase inhibitor indicated for adult patients with progressing desmoid tumors who require systemic treatm
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              age
              polarity
              not_inferred
              span
              end
              195
              end exclusive
              true
              exact text
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            regulatory links
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                exact text
                OGSIVEO is a gamma secretase inhibitor indicated for adult patients with progressing desmoid tumors who require systemic treatment.
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                source url
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                spl effective date
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                spl set id
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                structured fields status
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                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
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                brand names
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                clinical review status
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                end exclusive
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                exact text
                nts with progressing desmoid tumors who require systemic treatment. OGSIVEO is a gamma secretase inhibitor indicated for adult patients with progressing desmoid tumors who require systemic treatment. ( 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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                      structured indication
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                      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
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                      Preserved source evidence · Not medical advice