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LABELS · 41ec18e6-999d-f298-e063-6294a90aa2dc

BALVERSA

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
2025-10-24
Captured
2026-09-09T23:37:44.904352+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE BALVERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA [see Dosage and Administration (2.1) and Clinical Studies (14.1) ] . BALVERSA is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA. ( 1 , 2.1 ) Limitations of Use BALVERSA is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. ( 1 , 14.1 ) Limitations of Use BALVERSA is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy [see Clinical Studies (14.1) ] .
Full extracted label fields
application numbers
  1. NDA212018
boxed warning exact
    brand names
    1. BALVERSA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee
    generic names
    1. ERDAFITINIB
    id
    41ec18e6-999d-f298-e063-6294a90aa2dc
    indications and usage exact
    1. 1 INDICATIONS AND USAGE BALVERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA [see Dosage and Administration (2.1) and Clinical Studies (14.1) ] . BALVERSA is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA. ( 1 , 2.1 ) Limitations of Use BALVERSA is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. ( 1 , 14.1 ) Limitations of Use BALVERSA is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy [see Clinical Studies (14.1) ] .
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Janssen Products LP
      matched search terms
      1. carcinoma
      package ndcs
      1. 59676-040-28
      2. 59676-040-56
      3. 59676-030-56
      4. 59676-030-84
      5. 59676-050-28
      product ndcs
      1. 59676-030
      2. 59676-040
      3. 59676-050
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 2123131
        2. 2123137
        3. 2123139
        4. 2123141
        5. 2123143
        6. 2123145
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00200.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
        200
        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=200&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%2241ec18e6-999d-f298-e063-6294a90aa2dc%22
        spl effective date
        2025-10-24
        spl effective time
        20251024
        spl set id
        2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee
        spl version
        14
        substance names
        1. ERDAFITINIB
        uniis
        1. 890E37NHMV
        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
          NDA212018
          payload
          all indexed label documents
          1. Appl No
            212018
            Application Docs Date
            2019-04-12 00:00:00
            Application Docs ID
            58312
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            212018
            Application Docs Date
            2020-04-10 00:00:00
            Application Docs ID
            62541
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            SUPPL
          3. Appl No
            212018
            Application Docs Date
            2022-04-28 00:00:00
            Application Docs ID
            70846
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            3
            Submission Type
            SUPPL
          4. Appl No
            212018
            Application Docs Date
            2022-04-28 00:00:00
            Application Docs ID
            70847
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            SUPPL
          5. Appl No
            212018
            Application Docs Date
            2023-01-12 00:00:00
            Application Docs ID
            73146
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            4
            Submission Type
            SUPPL
          6. Appl No
            212018
            Application Docs Date
            2023-03-22 00:00:00
            Application Docs ID
            73813
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            5
            Submission Type
            SUPPL
          7. Appl No
            212018
            Application Docs Date
            2024-01-22 00:00:00
            Application Docs ID
            77258
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            7
            Submission Type
            SUPPL
          8. Appl No
            212018
            Application Docs Date
            2024-01-22 00:00:00
            Application Docs ID
            77259
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            8
            Submission Type
            SUPPL
          9. Appl No
            212018
            Application Docs Date
            2024-01-22 00:00:00
            Application Docs ID
            77260
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          10. Appl No
            212018
            Application Docs Date
            2024-10-10 00:00:00
            Application Docs ID
            79852
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            10
            Submission Type
            SUPPL
          11. Appl No
            212018
            Application Docs Date
            2025-10-20 00:00:00
            Application Docs ID
            83820
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            11
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            212018
            Review Priority
            PRIORITY
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2019-04-12 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            212018
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2020-04-02 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            212018
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2022-04-27 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            212018
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            3
            Submission Status
            AP
            Submission Status Date
            2022-04-27 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            212018
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            4
            Submission Status
            AP
            Submission Status Date
            2023-01-11 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            212018
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            5
            Submission Status
            AP
            Submission Status Date
            2023-03-20 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            212018
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            7
            Submission Status
            AP
            Submission Status Date
            2024-01-19 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            212018
            Review Priority
            PRIORITY
            Submission Class Code ID
            2
            Submission No
            8
            Submission Status
            AP
            Submission Status Date
            2024-01-19 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            212018
            Review Priority
            PRIORITY
            Submission Class Code ID
            2
            Submission No
            9
            Submission Status
            AP
            Submission Status Date
            2024-01-19 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            212018
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            10
            Submission Status
            AP
            Submission Status Date
            2024-10-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            212018
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            11
            Submission Status
            AP
            Submission Status Date
            2025-10-17 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA212018
          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
          2025-10-17
          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
            212018
            Application Docs Date
            2025-10-20 00:00:00
            Application Docs ID
            83820
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            11
            Submission Type
            SUPPL
          official application record
          Appl No
          212018
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          JANSSEN BIOTECH
          openfda application present
          true
          products
          1. Active Ingredient
            ERDAFITINIB
            Appl No
            212018
            Drug Name
            BALVERSA
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            3MG
            marketing status
            1. Prescription
          2. Active Ingredient
            ERDAFITINIB
            Appl No
            212018
            Drug Name
            BALVERSA
            Form
            TABLET;ORAL
            Product No
            002
            Reference Drug
            1
            Reference Standard
            0
            Strength
            4MG
            marketing status
            1. Prescription
          3. Active Ingredient
            ERDAFITINIB
            Appl No
            212018
            Drug Name
            BALVERSA
            Form
            TABLET;ORAL
            Product No
            003
            Reference Drug
            1
            Reference Standard
            1
            Strength
            5MG
            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. NDA212018
        brand names
        1. BALVERSA
        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
        473
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE BALVERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA [see Dosage and Administration (2.1) and Clinical Studies (14.1) ] . BALVERSA is a kinase inhibitor indicated fo
        label id
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        offset unit
        unicode_code_points
        source array index
        0
        source field
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        source text sha256
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        start
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        current approval status
        not_reconciled
        duplicate text group
        dup-d1c17ca672326bd8c7fe
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. ERDAFITINIB
        id
        ind-span-18b782a18a176954e514
        label id
        41ec18e6-999d-f298-e063-6294a90aa2dc
        positive predicate support span
        end
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        end exclusive
        true
        exact text
        is indicated
        label id
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        source text sha256
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        qualifier mentions
        1. context exact
          ATIONS AND USAGE BALVERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (m
          kind
          age
          polarity
          not_inferred
          span
          end
          81
          end exclusive
          true
          exact text
          adult patients
          label id
          41ec18e6-999d-f298-e063-6294a90aa2dc
          offset unit
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          source array index
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          source field
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          source text sha256
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        2. context exact
          or the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has prog
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          150
          end exclusive
          true
          exact text
          metastatic urothelial carcinoma (mUC) with
          label id
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        3. context exact
          d or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic th
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          207
          end exclusive
          true
          exact text
          FGFR3 genetic alterations whose disease has p
          label id
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          start
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        4. context exact
          VERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose dise
          kind
          stage_or_setting
          polarity
          not_inferred
          span
          end
          138
          end exclusive
          true
          exact text
          locally advanced or metastatic urothelial carcinoma
          label id
          41ec18e6-999d-f298-e063-6294a90aa2dc
          offset unit
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        5. context exact
          GFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy.
          kind
          prior_therapy_or_line
          polarity
          not_inferred
          span
          end
          272
          end exclusive
          true
          exact text
          after at least one line of prior systemic therapy
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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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            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE BALVERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy.
            label id
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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 · unclassified context
            application numbers
            1. NDA212018
            brand names
            1. BALVERSA
            classification reasons
            1. no_unambiguous_positive_indication_predicate
            clinical review status
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            content role
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            true
            exact text
            atients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA [see Dosage and Administration (2.1) and Clinical Studies (14.1) ] . BALVERSA is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease ha
            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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            current approval status
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            duplicate text group
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            extraction review status
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            generic names
            1. ERDAFITINIB
            id
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            label id
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            positive predicate support span
            Source null
            qualifier mentions
              regulatory links
                schema version
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                source batch sha256
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                source defined aliases
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                  end exclusive
                  true
                  exact text
                  Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA [see Dosage and Administration (2.1) and Clinical Studies (14.1) ] .
                  label id
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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
                  unclear
                  Passage 3 · positive indication candidate
                  application numbers
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                  brand names
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                                    Preserved source evidence · Not medical advice