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LABELS · 9d57dcc7-fa17-4ecf-ada1-3a4b1cf92032

MODEYSO

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
2026-01-09
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 MODEYSO is indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). MODEYSO is a protease activator indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. ( 1 ) This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Full extracted label fields
application numbers
  1. NDA219876
boxed warning exact
    brand names
    1. MODEYSO
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ad45b43e-fdef-47ad-9c34-055b41bdc576
    generic names
    1. DORDAVIPRONE
    id
    9d57dcc7-fa17-4ecf-ada1-3a4b1cf92032
    indications and usage exact
    1. 1 INDICATIONS AND USAGE MODEYSO is indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). MODEYSO is a protease activator indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. ( 1 ) This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Jazz Pharmaceuticals, Inc.
      matched search terms
      1. glioma
      package ndcs
      1. 68727-250-01
      product ndcs
      1. 68727-250
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 2721199
        2. 2721205
        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
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        url
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        source url
        https://api.fda.gov/drug/label.json?search=id%3A%229d57dcc7-fa17-4ecf-ada1-3a4b1cf92032%22
        spl effective date
        2026-01-09
        spl effective time
        20260109
        spl set id
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        spl version
        2
        substance names
        1. DORDAVIPRONE
        uniis
        1. 9U35A31JAI
        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
          NDA219876
          payload
          all indexed label documents
          1. Appl No
            219876
            Application Docs Date
            2025-08-06 00:00:00
            Application Docs ID
            83057
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          all submission records
          1. Appl No
            219876
            Review Priority
            PRIORITY
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2025-08-06 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
          NDA219876
          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
          2025-08-06
          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
            219876
            Application Docs Date
            2025-08-06 00:00:00
            Application Docs ID
            83057
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          official application record
          Appl No
          219876
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          CHIMERIX
          openfda application present
          true
          products
          1. Active Ingredient
            DORDAVIPRONE HYDROCHLORIDE
            Appl No
            219876
            Drug Name
            MODEYSO
            Form
            CAPSULE;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 125MG 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. NDA219876
        brand names
        1. MODEYSO
        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
        426
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE MODEYSO is indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent
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        extraction review status
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        generic names
        1. DORDAVIPRONE
        id
        ind-span-338dd4cfc7150b08152a
        label id
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        positive predicate support span
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        true
        exact text
        is indicated
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        qualifier mentions
        1. context exact
          CATIONS AND USAGE MODEYSO is indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse
          kind
          age
          polarity
          not_inferred
          span
          end
          71
          end exclusive
          true
          exact text
          adult
          label id
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        2. context exact
          D USAGE MODEYSO is indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harbori
          kind
          age
          polarity
          not_inferred
          span
          end
          94
          end exclusive
          true
          exact text
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        1. candidate source span
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          exact text
          1 INDICATIONS AND USAGE MODEYSO is indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
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          fda indication exact
          Treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
          fda source row index
          9
          fda source sha256
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          fda status record id
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          whole_fda_indication_text_present
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            exact text
            1 INDICATIONS AND USAGE MODEYSO is indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
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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
            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

            Read indication-specific status → · whole_fda_indication_text_present

            Passage 2 · approval contingency
            application numbers
            1. NDA219876
            brand names
            1. MODEYSO
            classification reasons
            1. approval_contingency_words
            clinical review status
            pending
            content role
            approval_contingency
            context span
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            569
            end exclusive
            true
            exact text
            EYSO is indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). MODEYSO is a protease activator indicated for the treatment
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            label id
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            positive predicate support span
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                  exact text
                  This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14 )] .
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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
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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
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                  Passage 3 · approval contingency
                  application numbers
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                  tation with progressive disease following prior therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). MODEYSO is a protease activator indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease
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                        Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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                        source url
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                        spl effective date
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                        Passage 4 · positive indication candidate
                        application numbers
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                        exact text
                        ate and duration of response [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). MODEYSO is a protease activator indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. ( 1 ) This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent u
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                        is a protease activator indicated
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                        qualifier mentions
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                          EYSO is a protease activator indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse
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                          polarity
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                        2. context exact
                          protease activator indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harbori
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                          polarity
                          not_inferred
                          span
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                          600
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                          exact text
                          MODEYSO is a protease activator indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
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                          fda indication exact
                          Treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
                          fda source row index
                          9
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                            MODEYSO is a protease activator indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
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                            Read indication-specific status → · whole_fda_indication_text_present

                            Passage 5 · approval contingency
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                            tivator indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. ( 1 ) This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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                                  mutation with progressive disease following prior therapy. ( 1 ) This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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                                        Preserved source evidence · Not medical advice