LABELS · dac17f96-6c26-41e4-bd42-92aff75d339e

ADSTILADRIN

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: 2026-03-24
Captured: 2026-09-09T23:38:02.384588+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE ADSTILADRIN ® is indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-Muscle Invasive Bladder Cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ( 1 )

Full extracted label fields

application numbers

BLA125700

boxed warning exact

brand names

ADSTILADRIN

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ca20ed4-da4f-463c-ac2a-ccd6ab3774fa

generic names

NADOFARAGENE FIRADENOVEC-VNCG

dac17f96-6c26-41e4-bd42-92aff75d339e

indications and usage exact

1 INDICATIONS AND USAGE ADSTILADRIN ® is indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-Muscle Invasive Bladder Cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ( 1 )

indications and usage tables exact

is original packager

true

manufacturer names

Ferring Pharmaceuticals Inc.

matched search terms

cancer
carcinoma
tumors

package ndcs

55566-1050-0
55566-1050-1
55566-1050-2

product ndcs

55566-1050

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Dosage and Administration ( 2.2 ) 03/2026

record type

complete_spl_indications_section_candidate

routes

INTRAVESICAL

rxcuis

2644440
2644445

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00700.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

license

https://open.fda.gov/license/

results

limit: 100
skip: 700
total: 830

terms

https://open.fda.gov/terms/

sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%22dac17f96-6c26-41e4-bd42-92aff75d339e%22

spl effective date

2026-03-24

spl effective time

20260324

spl set id

5ca20ed4-da4f-463c-ac2a-ccd6ab3774fa

spl version

substance names

NADOFARAGENE FIRADENOVEC

uniis

0OOS09O1FH

verification flags

oncology_keyword_candidate_not_clinically_classified
spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled
no_matched_approved_submission
application_missing_from_drugsfda_bulk

Drugs@FDA application source records

application number
BLA125700
payload
all indexed label documents
all submission records
application number
BLA125700
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125700
has approved submission record
false
latest approved submission date
Source null
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
official application record
Source null
openfda application present
false
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

BLA125700

brand names

ADSTILADRIN

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 451
end exclusive: true
exact text: 1 INDICATIONS AND USAGE ADSTILADRIN ® is indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-Muscle Invasive Bladder Cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive blad
label id: dac17f96-6c26-41e4-bd42-92aff75d339e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c4a2ea03e504e69ee6f91db627f8ef47781396205cecc46a95cb366bf31c7415
start: 0

current approval status

not_reconciled

duplicate text group

dup-d48c03aa1cb101415da8

extraction review status

automated_candidate_pending_source_review

generic names

NADOFARAGENE FIRADENOVEC-VNCG

ind-span-f088199f89affcb7a6dd

label id

dac17f96-6c26-41e4-bd42-92aff75d339e

positive predicate support span

end: 50
end exclusive: true
exact text: is indicated
label id: dac17f96-6c26-41e4-bd42-92aff75d339e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c4a2ea03e504e69ee6f91db627f8ef47781396205cecc46a95cb366bf31c7415
start: 38

qualifier mentions

context exact
S AND USAGE ADSTILADRIN ® is indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive
kind
age
polarity
not_inferred
span
end
86
end exclusive
true
exact text
adult patients
label id
dac17f96-6c26-41e4-bd42-92aff75d339e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c4a2ea03e504e69ee6f91db627f8ef47781396205cecc46a95cb366bf31c7415
start
72
context exact
nvasive Bladder Cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
kind
regimen
polarity
not_inferred
span
end
250
end exclusive
true
exact text
with or without papillary tumors
label id
dac17f96-6c26-41e4-bd42-92aff75d339e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c4a2ea03e504e69ee6f91db627f8ef47781396205cecc46a95cb366bf31c7415
start
218

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 251
end exclusive: true
exact text: 1 INDICATIONS AND USAGE ADSTILADRIN ® is indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-Muscle Invasive Bladder Cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
label id: dac17f96-6c26-41e4-bd42-92aff75d339e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c4a2ea03e504e69ee6f91db627f8ef47781396205cecc46a95cb366bf31c7415
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%22dac17f96-6c26-41e4-bd42-92aff75d339e%22

spl effective date

2026-03-24

spl set id

5ca20ed4-da4f-463c-ac2a-ccd6ab3774fa

spl version

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

Passage 2 · positive indication candidate

application numbers

BLA125700

brand names

ADSTILADRIN

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 538
end exclusive: true
exact text: or the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-Muscle Invasive Bladder Cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ( 1 )
label id: dac17f96-6c26-41e4-bd42-92aff75d339e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c4a2ea03e504e69ee6f91db627f8ef47781396205cecc46a95cb366bf31c7415
start: 52

current approval status

not_reconciled

duplicate text group

dup-b9ceca29d6d124f0e484

extraction review status

automated_candidate_pending_source_review

generic names

NADOFARAGENE FIRADENOVEC-VNCG

ind-span-b0c2ad6fe81056656be7

label id

dac17f96-6c26-41e4-bd42-92aff75d339e

positive predicate support span

end: 331
end exclusive: true
exact text: is a non-replicating adenoviral vector-based gene therapy indicated
label id: dac17f96-6c26-41e4-bd42-92aff75d339e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c4a2ea03e504e69ee6f91db627f8ef47781396205cecc46a95cb366bf31c7415
start: 264

qualifier mentions

context exact
al vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive
kind
age
polarity
not_inferred
span
end
367
end exclusive
true
exact text
adult patients
label id
dac17f96-6c26-41e4-bd42-92aff75d339e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c4a2ea03e504e69ee6f91db627f8ef47781396205cecc46a95cb366bf31c7415
start
353
context exact
nvasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
kind
regimen
polarity
not_inferred
span
end
531
end exclusive
true
exact text
with or without papillary tumors
label id
dac17f96-6c26-41e4-bd42-92aff75d339e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c4a2ea03e504e69ee6f91db627f8ef47781396205cecc46a95cb366bf31c7415
start
499

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 532
end exclusive: true
exact text: ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
label id: dac17f96-6c26-41e4-bd42-92aff75d339e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c4a2ea03e504e69ee6f91db627f8ef47781396205cecc46a95cb366bf31c7415
start: 252

source url

https://api.fda.gov/drug/label.json?search=id%3A%22dac17f96-6c26-41e4-bd42-92aff75d339e%22

spl effective date

2026-03-24

spl set id

5ca20ed4-da4f-463c-ac2a-ccd6ab3774fa

spl version

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

Passage 3 · unclassified context

application numbers

BLA125700

brand names

ADSTILADRIN

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 538
end exclusive: true
exact text: or the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ( 1 )
label id: dac17f96-6c26-41e4-bd42-92aff75d339e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c4a2ea03e504e69ee6f91db627f8ef47781396205cecc46a95cb366bf31c7415
start: 333

current approval status

not_reconciled

duplicate text group

dup-4757dff31695691742bd

extraction review status

automated_candidate_pending_source_review

generic names

NADOFARAGENE FIRADENOVEC-VNCG

ind-span-71a33c40aa0d904b65bc

label id

dac17f96-6c26-41e4-bd42-92aff75d339e

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 538
end exclusive: true
exact text: ( 1 )
label id: dac17f96-6c26-41e4-bd42-92aff75d339e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c4a2ea03e504e69ee6f91db627f8ef47781396205cecc46a95cb366bf31c7415
start: 533

source url

https://api.fda.gov/drug/label.json?search=id%3A%22dac17f96-6c26-41e4-bd42-92aff75d339e%22

spl effective date

2026-03-24

spl set id

5ca20ed4-da4f-463c-ac2a-ccd6ab3774fa

spl version

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