LABELS · 4044189e-1cb5-b6f5-e063-6394a90aeb7e

PROVENGE

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: 2025-10-03
Captured: 2026-09-09T23:37:44.904352+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE PROVENGE ® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. ( 1 )

Full extracted label fields

application numbers

BLA125197

boxed warning exact

brand names

PROVENGE

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8309b497-5d4e-4408-ac0c-2452c11c8a35

generic names

SIPULEUCEL-T

4044189e-1cb5-b6f5-e063-6394a90aeb7e

indications and usage exact

1 INDICATIONS AND USAGE PROVENGE ® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. ( 1 )

indications and usage tables exact

is original packager

true

manufacturer names

Dendreon Pharmaceuticals LLC

matched search terms

cancer

package ndcs

30237-8900-5
30237-8900-6

product ndcs

30237-8900

product types

CELLULAR THERAPY

recent major changes exact

Dosage and Administration Administration ( 2.2 ) 9/2014 Warnings and Precautions Acute Infusion Reactions ( 5.1 ) 10/2014 Thromboembolic Events ( 5.2 ) 10/2014 Vascular Disorders ( 5.3 ) 10/2014

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS

rxcuis

997264
997267

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

license

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

results

limit: 100
skip: 200
total: 830

terms

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

sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%224044189e-1cb5-b6f5-e063-6394a90aeb7e%22

spl effective date

2025-10-03

spl effective time

20251003

spl set id

8309b497-5d4e-4408-ac0c-2452c11c8a35

spl version

substance names

SIPULEUCEL-T

uniis

8Q622VDR18

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
BLA125197
payload
all indexed label documents
all submission records
application number
BLA125197
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=125197
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

BLA125197

brand names

PROVENGE

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: 418
end exclusive: true
exact text: 1 INDICATIONS AND USAGE PROVENGE ® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. ( 1 )
label id: 4044189e-1cb5-b6f5-e063-6394a90aeb7e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 420d96e40749a285aedf459fc7679b169879d15f61c05c2c807ff29ca995d469
start: 0

current approval status

not_reconciled

duplicate text group

dup-cacc85f2154bd37bc983

extraction review status

automated_candidate_pending_source_review

generic names

SIPULEUCEL-T

ind-span-2b675e2159480931dbcb

label id

4044189e-1cb5-b6f5-e063-6394a90aeb7e

positive predicate support span

end: 99
end exclusive: true
exact text: is an autologous cellular immunotherapy indicated
label id: 4044189e-1cb5-b6f5-e063-6394a90aeb7e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 420d96e40749a285aedf459fc7679b169879d15f61c05c2c807ff29ca995d469
start: 50

qualifier mentions

context exact
for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.
kind
biomarker
polarity
not_inferred
span
end
202
end exclusive
true
exact text
metastatic castrate-resistant (hormone-refr
label id
4044189e-1cb5-b6f5-e063-6394a90aeb7e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
420d96e40749a285aedf459fc7679b169879d15f61c05c2c807ff29ca995d469
start
159
context exact
for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.
kind
stage_or_setting
polarity
not_inferred
span
end
204
end exclusive
true
exact text
metastatic castrate-resistant (hormone-refrac
label id
4044189e-1cb5-b6f5-e063-6394a90aeb7e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
420d96e40749a285aedf459fc7679b169879d15f61c05c2c807ff29ca995d469
start
159

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 226
end exclusive: true
exact text: 1 INDICATIONS AND USAGE PROVENGE ® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.
label id: 4044189e-1cb5-b6f5-e063-6394a90aeb7e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 420d96e40749a285aedf459fc7679b169879d15f61c05c2c807ff29ca995d469
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%224044189e-1cb5-b6f5-e063-6394a90aeb7e%22

spl effective date

2025-10-03

spl set id

8309b497-5d4e-4408-ac0c-2452c11c8a35

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

BLA125197

brand names

PROVENGE

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: 418
end exclusive: true
exact text: VENGE ® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. ( 1 )
label id: 4044189e-1cb5-b6f5-e063-6394a90aeb7e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 420d96e40749a285aedf459fc7679b169879d15f61c05c2c807ff29ca995d469
start: 27

current approval status

not_reconciled

duplicate text group

dup-bab5b0b7e68d04e0c1f9

extraction review status

automated_candidate_pending_source_review

generic names

SIPULEUCEL-T

ind-span-e98b990446221b88ecf8

label id

4044189e-1cb5-b6f5-e063-6394a90aeb7e

positive predicate support span

end: 285
end exclusive: true
exact text: is an autologous cellular immunotherapy indicated
label id: 4044189e-1cb5-b6f5-e063-6394a90aeb7e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 420d96e40749a285aedf459fc7679b169879d15f61c05c2c807ff29ca995d469
start: 236

qualifier mentions

context exact
for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.
kind
biomarker
polarity
not_inferred
span
end
388
end exclusive
true
exact text
metastatic castrate-resistant (hormone-refr
label id
4044189e-1cb5-b6f5-e063-6394a90aeb7e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
420d96e40749a285aedf459fc7679b169879d15f61c05c2c807ff29ca995d469
start
345
context exact
for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.
kind
stage_or_setting
polarity
not_inferred
span
end
390
end exclusive
true
exact text
metastatic castrate-resistant (hormone-refrac
label id
4044189e-1cb5-b6f5-e063-6394a90aeb7e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
420d96e40749a285aedf459fc7679b169879d15f61c05c2c807ff29ca995d469
start
345

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 412
end exclusive: true
exact text: PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.
label id: 4044189e-1cb5-b6f5-e063-6394a90aeb7e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 420d96e40749a285aedf459fc7679b169879d15f61c05c2c807ff29ca995d469
start: 227

source url

https://api.fda.gov/drug/label.json?search=id%3A%224044189e-1cb5-b6f5-e063-6394a90aeb7e%22

spl effective date

2025-10-03

spl set id

8309b497-5d4e-4408-ac0c-2452c11c8a35

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

BLA125197

brand names

PROVENGE

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 418
end exclusive: true
exact text: state cancer. PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. ( 1 )
label id: 4044189e-1cb5-b6f5-e063-6394a90aeb7e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 420d96e40749a285aedf459fc7679b169879d15f61c05c2c807ff29ca995d469
start: 213

current approval status

not_reconciled

duplicate text group

dup-00e99d26275dbc5dc755

extraction review status

automated_candidate_pending_source_review

generic names

SIPULEUCEL-T

ind-span-cc011c8c85effd694aa3

label id

4044189e-1cb5-b6f5-e063-6394a90aeb7e

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 418
end exclusive: true
exact text: ( 1 )
label id: 4044189e-1cb5-b6f5-e063-6394a90aeb7e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 420d96e40749a285aedf459fc7679b169879d15f61c05c2c807ff29ca995d469
start: 413

source url

https://api.fda.gov/drug/label.json?search=id%3A%224044189e-1cb5-b6f5-e063-6394a90aeb7e%22

spl effective date

2025-10-03

spl set id

8309b497-5d4e-4408-ac0c-2452c11c8a35

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