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LABELS · 5a6cd8e9-9d15-d428-e063-6294a90a4dfb

Tudriqev

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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
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE TUDRIQEV™ is indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response [ see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). TUDRIQEV is a genetically modified oncolytic viral therapy indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ( 1 )
Full extracted label fields
application numbers
  1. BLA125827
boxed warning exact
    brand names
    1. Tudriqev
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=26627b8d-91ac-4f76-a213-7e25efd024d1
    generic names
    1. VUSOLIMOGENE ODERPAREPVEC-WTPG
    id
    5a6cd8e9-9d15-d428-e063-6294a90a4dfb
    indications and usage exact
    1. 1 INDICATIONS AND USAGE TUDRIQEV™ is indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response [ see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). TUDRIQEV is a genetically modified oncolytic viral therapy indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Replimune, Inc.
      matched search terms
      1. melanoma
      package ndcs
      1. 83616-106-01
      2. 83616-106-11
      3. 83616-107-01
      4. 83616-107-11
      product ndcs
      1. 83616-106
      2. 83616-107
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
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          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
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          source url
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          spl effective date
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          spl effective time
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          substance names
          1. VUSOLIMOGENE ODERPAREPVEC
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          Drugs@FDA application source records
          1. application number
            BLA125827
            payload
            all indexed label documents
              all submission records
                application number
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                approval interpretation
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                current indication status
                not_reconciled
                has approved submission record
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                Source null
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                  products

                  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. BLA125827
                  brand names
                  1. Tudriqev
                  classification reasons
                  1. explicit_positive_indication_predicate
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                  exact text
                  1 INDICATIONS AND USAGE TUDRIQEV™ is indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response [ see Clinical Studies (14) ]. Continued approval for this indication may be con
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                  qualifier mentions
                  1. context exact
                    ndicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienc
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                    unresectable advanced cutaneous melanoma who ex
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                  3. context exact
                    1 INDICATIONS AND USAGE TUDRIQEV™ is indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.
                    kind
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                    in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death recepto
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                      exact text
                      1 INDICATIONS AND USAGE TUDRIQEV™ is indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.
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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 · approval contingency
                      application numbers
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                      1. approval_contingency_words
                      clinical review status
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                      exact text
                      olumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response [ see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). TUDRIQEV is a genetically modified oncolytic viral therapy indicated in comb
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                      label id
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                      positive predicate support span
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                            This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response [ see Clinical Studies (14) ].
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                            spl effective date
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                            Source null
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                            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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                            brand names
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                            exact text
                            eceptor-1 (PD-1)-blocking antibody-based regimen. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response [ see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). TUDRIQEV is a genetically modified oncolytic viral therapy indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced di
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                                  Passage 4 · positive indication candidate
                                  application numbers
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                                  brand names
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                                  response rate (ORR) and duration of response [ see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). TUDRIQEV is a genetically modified oncolytic viral therapy indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification of c
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                                  is a genetically modified oncolytic viral therapy indicated
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                                    ndicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienc
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                                    unresectable advanced cutaneous melanoma who ex
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                                  3. context exact
                                    is a genetically modified oncolytic viral therapy indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.
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                                    regimen
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                                    exact text
                                    in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death recepto
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                                      TUDRIQEV is a genetically modified oncolytic viral therapy indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.
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                                      olumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ( 1 )
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                                            This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response.
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                                            sion with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ( 1 )
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                                                        Preserved source evidence · Not medical advice