LABELS · 5a6cd8e9-9d15-d428-e063-6294a90a4dfb
Tudriqev
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
- 2026-09-09T23:37:47.659725+00:00
- Current indication reconciliation
- Not reconciled
Indications and usage: exact source 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 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
- BLA125827
- boxed warning exact
- brand names
- 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
- VUSOLIMOGENE ODERPAREPVEC-WTPG
- id
- 5a6cd8e9-9d15-d428-e063-6294a90a4dfb
- indications and usage 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. 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
- true
- manufacturer names
- Replimune, Inc.
- matched search terms
- melanoma
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- 83616-106-01
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- product types
- HUMAN PRESCRIPTION DRUG
- recent major changes exact
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- INTRATUMOR
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- file
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- 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
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Drugs@FDA application source records
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Source passages and status connections
Passage 1 · positive indication candidate
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- 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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- 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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Passage 2 · approval contingency
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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 [ 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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Passage 3 · approval contingency
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- 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
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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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Passage 5 · approval contingency
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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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- 835
- source url
- https://api.fda.gov/drug/label.json?search=id%3A%225a6cd8e9-9d15-d428-e063-6294a90a4dfb%22
- spl effective date
- 2026-09-01
- spl set id
- 26627b8d-91ac-4f76-a213-7e25efd024d1
- spl version
- 3
- 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
- not_applicable
Passage 6 · approval contingency
- application numbers
- BLA125827
- brand names
- Tudriqev
- classification reasons
- approval_contingency_words
- clinical review status
- pending
- content role
- approval_contingency
- context span
- end
- 1083
- end exclusive
- true
- exact text
- 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 )
- label id
- 5a6cd8e9-9d15-d428-e063-6294a90a4dfb
- offset unit
- unicode_code_points
- source array index
- 0
- source field
- indications_and_usage_exact
- source text sha256
- d3b1d8424b56dc4e5e84160baa969163a61c7044830e54818c2d43e2904ece84
- start
- 755
- current approval status
- not_reconciled
- duplicate text group
- dup-e17cf8c19d226f5b0620
- extraction review status
- automated_candidate_pending_source_review
- generic names
- VUSOLIMOGENE ODERPAREPVEC-WTPG
- id
- ind-span-12ee351b570d374ea0ef
- label id
- 5a6cd8e9-9d15-d428-e063-6294a90a4dfb
- positive predicate support span
- Source null
- qualifier mentions
- regulatory links
- schema version
- 0.1.0
- source batch sha256
- bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
- source defined aliases
- source span
- end
- 1077
- end exclusive
- true
- exact text
- Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).
- label id
- 5a6cd8e9-9d15-d428-e063-6294a90a4dfb
- offset unit
- unicode_code_points
- source array index
- 0
- source field
- indications_and_usage_exact
- source text sha256
- d3b1d8424b56dc4e5e84160baa969163a61c7044830e54818c2d43e2904ece84
- start
- 955
- source url
- https://api.fda.gov/drug/label.json?search=id%3A%225a6cd8e9-9d15-d428-e063-6294a90a4dfb%22
- spl effective date
- 2026-09-01
- spl set id
- 26627b8d-91ac-4f76-a213-7e25efd024d1
- spl version
- 3
- 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
- not_applicable
Passage 7 · unclassified context
- application numbers
- BLA125827
- brand names
- Tudriqev
- classification reasons
- no_unambiguous_positive_indication_predicate
- clinical review status
- pending
- content role
- unclassified_context
- context span
- end
- 1083
- end exclusive
- true
- exact text
- ed 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 )
- label id
- 5a6cd8e9-9d15-d428-e063-6294a90a4dfb
- offset unit
- unicode_code_points
- source array index
- 0
- source field
- indications_and_usage_exact
- source text sha256
- d3b1d8424b56dc4e5e84160baa969163a61c7044830e54818c2d43e2904ece84
- start
- 878
- current approval status
- not_reconciled
- duplicate text group
- dup-7f18f1655d2fcd48ec94
- extraction review status
- automated_candidate_pending_source_review
- generic names
- VUSOLIMOGENE ODERPAREPVEC-WTPG
- id
- ind-span-065e34ad6248d225617f
- label id
- 5a6cd8e9-9d15-d428-e063-6294a90a4dfb
- positive predicate support span
- Source null
- qualifier mentions
- regulatory links
- schema version
- 0.1.0
- source batch sha256
- bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
- source defined aliases
- source span
- end
- 1083
- end exclusive
- true
- exact text
- ( 1 )
- label id
- 5a6cd8e9-9d15-d428-e063-6294a90a4dfb
- offset unit
- unicode_code_points
- source array index
- 0
- source field
- indications_and_usage_exact
- source text sha256
- d3b1d8424b56dc4e5e84160baa969163a61c7044830e54818c2d43e2904ece84
- start
- 1078
- source url
- https://api.fda.gov/drug/label.json?search=id%3A%225a6cd8e9-9d15-d428-e063-6294a90a4dfb%22
- spl effective date
- 2026-09-01
- spl set id
- 26627b8d-91ac-4f76-a213-7e25efd024d1
- spl version
- 3
- 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
- unclear
Preserved source evidence · Not medical advice
Triangle