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LABELS · a1ac4da0-35e5-45c3-818b-4a76dbfb0279

ROMVIMZA

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
2026-06-26
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 ROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. ROMVIMZA is a kinase inhibitor indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. ( 1 )
Full extracted label fields
application numbers
  1. NDA219304
boxed warning exact
    brand names
    1. ROMVIMZA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f73c7a62-9601-4df0-810f-100f515d79ea
    generic names
    1. VIMSELTINIB
    id
    a1ac4da0-35e5-45c3-818b-4a76dbfb0279
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. ROMVIMZA is a kinase inhibitor indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Deciphera Pharmaceuticals, LLC
      matched search terms
      1. tumor
      package ndcs
      1. 73207-302-41
      2. 73207-302-40
      3. 73207-303-41
      4. 73207-303-40
      5. 73207-304-41
      6. 73207-304-40
      product ndcs
      1. 73207-302
      2. 73207-303
      3. 73207-304
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 2705406
        2. 2705412
        3. 2705414
        4. 2705416
        5. 2705418
        6. 2705420
        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%22a1ac4da0-35e5-45c3-818b-4a76dbfb0279%22
        spl effective date
        2026-06-26
        spl effective time
        20260626
        spl set id
        f73c7a62-9601-4df0-810f-100f515d79ea
        spl version
        3
        substance names
        1. VIMSELTINIB
        uniis
        1. PX9FTM69BF
        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
          NDA219304
          payload
          all indexed label documents
          1. Appl No
            219304
            Application Docs Date
            2025-02-18 00:00:00
            Application Docs ID
            81267
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            219304
            Application Docs Date
            2026-05-21 00:00:00
            Application Docs ID
            85996
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            SUPPL
          3. Appl No
            219304
            Application Docs Date
            2026-07-06 00:00:00
            Application Docs ID
            86464
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            219304
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2026-06-26 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            219304
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2025-12-12 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            219304
            Review Priority
            PRIORITY
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2025-02-14 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
          NDA219304
          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
          2026-06-26
          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
            219304
            Application Docs Date
            2026-07-06 00:00:00
            Application Docs ID
            86464
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            SUPPL
          official application record
          Appl No
          219304
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          DECIPHERA PHARMS
          openfda application present
          true
          products
          1. Active Ingredient
            VIMSELTINIB
            Appl No
            219304
            Drug Name
            ROMVIMZA
            Form
            CAPSULE;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            14MG
            marketing status
            1. Prescription
          2. Active Ingredient
            VIMSELTINIB
            Appl No
            219304
            Drug Name
            ROMVIMZA
            Form
            CAPSULE;ORAL
            Product No
            002
            Reference Drug
            1
            Reference Standard
            0
            Strength
            20MG
            marketing status
            1. Prescription
          3. Active Ingredient
            VIMSELTINIB
            Appl No
            219304
            Drug Name
            ROMVIMZA
            Form
            CAPSULE;ORAL
            Product No
            003
            Reference Drug
            1
            Reference Standard
            1
            Strength
            30MG
            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. NDA219304
        brand names
        1. ROMVIMZA
        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
        436
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE ROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. ROMVIMZA is a kinase inhibitor indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional
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        source text sha256
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        extraction review status
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        generic names
        1. VIMSELTINIB
        id
        ind-span-e698a202957497becd04
        label id
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        positive predicate support span
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        exact text
        is indicated
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        source text sha256
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        start
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        qualifier mentions
        1. context exact
          NDICATIONS AND USAGE ROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for w
          kind
          age
          polarity
          not_inferred
          span
          end
          77
          end exclusive
          true
          exact text
          adult patients
          label id
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          source text sha256
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        regulatory links
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            exact text
            1 INDICATIONS AND USAGE ROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.
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            source text sha256
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            source url
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            spl effective date
            2026-06-26
            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. NDA219304
            brand names
            1. ROMVIMZA
            classification reasons
            1. explicit_positive_indication_predicate
            2. tumor_or_malignant_hematology_words_in_positive_statement
            clinical review status
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            exact text
            ndicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. ROMVIMZA is a kinase inhibitor indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. ( 1 )
            label id
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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
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            label id
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            true
            exact text
            is a kinase inhibitor indicated
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            offset unit
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            qualifier mentions
            1. context exact
              ROMVIMZA is a kinase inhibitor indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for w
              kind
              age
              polarity
              not_inferred
              span
              end
              309
              end exclusive
              true
              exact text
              adult patients
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            regulatory links
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                end exclusive
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                exact text
                ROMVIMZA is a kinase inhibitor indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.
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                source text sha256
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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
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                Passage 3 · unclassified context
                application numbers
                1. NDA219304
                brand names
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                exact text
                ndicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. ( 1 )
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                      source url
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                      spl effective date
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                      approval pathway
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                      biomarker and test
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                      disease stage
                      Source null
                      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