LABELS · b653221e-971f-4452-92d4-797924f1ff59

Talzenna

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: 2024-07-09
Captured: 2026-09-09T23:37:58.719708+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for: Breast Cancer • As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA. ( 1.1 ) HRR Gene-Mutated mCRPC • In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). ( 1.2 ) 1.1 BRCA -mutated (g BRCA m) HER2-negative Locally Advanced or Metastatic Breast Cancer TALZENNA is indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene ( BRCA )-mutated (g BRCA m) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA [see Dosage and Administration (2.1) ] . 1.2 HRR Gene-mutated mCRPC TALZENNA is indicated in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) [see Dosage and Administration (2.3) ] .

Full extracted label fields

application numbers

NDA217439

boxed warning exact

brand names

Talzenna

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b653221e-971f-4452-92d4-797924f1ff59

generic names

TALAZOPARIB

b653221e-971f-4452-92d4-797924f1ff59

indications and usage exact

1 INDICATIONS AND USAGE TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for: Breast Cancer • As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA. ( 1.1 ) HRR Gene-Mutated mCRPC • In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). ( 1.2 ) 1.1 BRCA -mutated (g BRCA m) HER2-negative Locally Advanced or Metastatic Breast Cancer TALZENNA is indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene ( BRCA )-mutated (g BRCA m) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA [see Dosage and Administration (2.1) ] . 1.2 HRR Gene-mutated mCRPC TALZENNA is indicated in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) [see Dosage and Administration (2.3) ] .

indications and usage tables exact

is original packager

true

manufacturer names

U.S. Pharmaceuticals

matched search terms

cancer

package ndcs

63539-025-30
63539-031-30

product ndcs

63539-025
63539-031

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

2099954
2099956
2591510
2591512

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00600.json

Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · indication intro context

application numbers

NDA217439

brand names

Talzenna

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement
incomplete_colon_led_indication_intro

clinical review status

pending

content role

indication_intro_context

context span

end: 312
end exclusive: true
exact text: 1 INDICATIONS AND USAGE TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for: Breast Cancer • As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer. Select
label id: b653221e-971f-4452-92d4-797924f1ff59
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start: 0

current approval status

not_reconciled

duplicate text group

dup-6ec609ac8cb25b323ff8

extraction review status

automated_candidate_pending_source_review

generic names

TALAZOPARIB

ind-span-58f1c40c302a2199546a

label id

b653221e-971f-4452-92d4-797924f1ff59

positive predicate support span

end: 93
end exclusive: true
exact text: is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated
label id: b653221e-971f-4452-92d4-797924f1ff59
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start: 33

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 112
end exclusive: true
exact text: 1 INDICATIONS AND USAGE TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for: Breast Cancer
label id: b653221e-971f-4452-92d4-797924f1ff59
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%22b653221e-971f-4452-92d4-797924f1ff59%22

spl effective date

2024-07-09

spl set id

b653221e-971f-4452-92d4-797924f1ff59

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

not_applicable

Passage 2 · positive indication candidate

application numbers

NDA217439

brand names

Talzenna

classification reasons

inherited_predicate_from_same_label_section_requires_review
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 505
end exclusive: true
exact text: 1 INDICATIONS AND USAGE TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for: Breast Cancer • As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA. ( 1.1 ) HRR Gene-Mutated mCRPC • In combination with enzalutamide for the treatment of adult patients with HRR
label id: b653221e-971f-4452-92d4-797924f1ff59
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start: 0

current approval status

not_reconciled

duplicate text group

dup-b37d0f6a9ec5d263cb42

extraction review status

automated_candidate_pending_source_review

generic names

TALAZOPARIB

ind-span-de74bbf27e8a645a75d6

label id

b653221e-971f-4452-92d4-797924f1ff59

positive predicate support span

end: 93
end exclusive: true
exact text: is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated
label id: b653221e-971f-4452-92d4-797924f1ff59
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start: 33

qualifier mentions

context exact
• As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mu
kind
age
polarity
not_inferred
span
end
169
end exclusive
true
exact text
adult patients
label id
b653221e-971f-4452-92d4-797924f1ff59
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start
155
context exact
patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer.
kind
biomarker
polarity
not_inferred
span
end
265
end exclusive
true
exact text
BRCA -mutated (g BRCA m) HER2-negative local
label id
b653221e-971f-4452-92d4-797924f1ff59
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start
221
context exact
BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer.
kind
biomarker
polarity
not_inferred
span
end
304
end exclusive
true
exact text
metastatic breast cancer
label id
b653221e-971f-4452-92d4-797924f1ff59
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start
280
context exact
deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer.
kind
stage_or_setting
polarity
not_inferred
span
end
304
end exclusive
true
exact text
locally advanced or metastatic breast cancer
label id
b653221e-971f-4452-92d4-797924f1ff59
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start
260
context exact
• As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer.
kind
regimen
polarity
not_inferred
span
end
292
end exclusive
true
exact text
As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic b
label id
b653221e-971f-4452-92d4-797924f1ff59
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start
115

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 305
end exclusive: true
exact text: • As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer.
label id: b653221e-971f-4452-92d4-797924f1ff59
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start: 113

source url

https://api.fda.gov/drug/label.json?search=id%3A%22b653221e-971f-4452-92d4-797924f1ff59%22

spl effective date

2024-07-09

spl set id

b653221e-971f-4452-92d4-797924f1ff59

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

NDA217439

brand names

Talzenna

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 593
end exclusive: true
exact text: Cancer • As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA. ( 1.1 ) HRR Gene-Mutated mCRPC • In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). ( 1.2 ) 1.1 BRCA -
label id: b653221e-971f-4452-92d4-797924f1ff59
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start: 106

current approval status

not_reconciled

duplicate text group

dup-161fff5daf110742e39d

extraction review status

automated_candidate_pending_source_review

generic names

TALAZOPARIB

ind-span-27c6466f2c1360684dbd

label id

b653221e-971f-4452-92d4-797924f1ff59

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 393
end exclusive: true
exact text: Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA.
label id: b653221e-971f-4452-92d4-797924f1ff59
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start: 306

source url

https://api.fda.gov/drug/label.json?search=id%3A%22b653221e-971f-4452-92d4-797924f1ff59%22

spl effective date

2024-07-09

spl set id

b653221e-971f-4452-92d4-797924f1ff59

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

Passage 4 · unclassified context

application numbers

NDA217439

brand names

Talzenna

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 624
end exclusive: true
exact text: ected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA. ( 1.1 ) HRR Gene-Mutated mCRPC • In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). ( 1.2 ) 1.1 BRCA -mutated (g BRCA m) HER2-negativ
label id: b653221e-971f-4452-92d4-797924f1ff59
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start: 194

current approval status

not_reconciled

duplicate text group

dup-fe41618bc0255b70fe09

extraction review status

automated_candidate_pending_source_review

generic names

TALAZOPARIB

ind-span-0f71ea1bf2c4f623641c

label id

b653221e-971f-4452-92d4-797924f1ff59

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 424
end exclusive: true
exact text: ( 1.1 ) HRR Gene-Mutated mCRPC
label id: b653221e-971f-4452-92d4-797924f1ff59
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start: 394

source url

https://api.fda.gov/drug/label.json?search=id%3A%22b653221e-971f-4452-92d4-797924f1ff59%22

spl effective date

2024-07-09

spl set id

b653221e-971f-4452-92d4-797924f1ff59

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

Passage 5 · positive indication candidate

application numbers

NDA217439

brand names

Talzenna

classification reasons

inherited_predicate_from_same_label_section_requires_review
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 774
end exclusive: true
exact text: -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA. ( 1.1 ) HRR Gene-Mutated mCRPC • In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). ( 1.2 ) 1.1 BRCA -mutated (g BRCA m) HER2-negative Locally Advanced or Metastatic Breast Cancer TALZENNA is indicated as a single agent for the treatment of adult patients with deleterious or suspect
label id: b653221e-971f-4452-92d4-797924f1ff59
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start: 225

current approval status

not_reconciled

duplicate text group

dup-8074b73401da44dc4419

extraction review status

automated_candidate_pending_source_review

generic names

TALAZOPARIB

ind-span-eef7a537fc3e8d8d0894

label id

b653221e-971f-4452-92d4-797924f1ff59

positive predicate support span

end: 93
end exclusive: true
exact text: is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated
label id: b653221e-971f-4452-92d4-797924f1ff59
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start: 33

qualifier mentions

context exact
• In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prost
kind
age
polarity
not_inferred
span
end
495
end exclusive
true
exact text
adult patients
label id
b653221e-971f-4452-92d4-797924f1ff59
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start
481
context exact
e for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
kind
biomarker
polarity
not_inferred
span
end
561
end exclusive
true
exact text
metastatic castration-resistant prostate ca
label id
b653221e-971f-4452-92d4-797924f1ff59
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start
518
context exact
e for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
kind
stage_or_setting
polarity
not_inferred
span
end
563
end exclusive
true
exact text
metastatic castration-resistant prostate canc
label id
b653221e-971f-4452-92d4-797924f1ff59
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start
518
context exact
• In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
kind
regimen
polarity
not_inferred
span
end
573
end exclusive
true
exact text
In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC)
label id
b653221e-971f-4452-92d4-797924f1ff59
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start
427

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 574
end exclusive: true
exact text: • In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
label id: b653221e-971f-4452-92d4-797924f1ff59
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start: 425

source url

https://api.fda.gov/drug/label.json?search=id%3A%22b653221e-971f-4452-92d4-797924f1ff59%22

spl effective date

2024-07-09

spl set id

b653221e-971f-4452-92d4-797924f1ff59

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 6 · unclassified context

application numbers

NDA217439

brand names

Talzenna

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 782
end exclusive: true
exact text: stic for TALZENNA. ( 1.1 ) HRR Gene-Mutated mCRPC • In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). ( 1.2 ) 1.1 BRCA -mutated (g BRCA m) HER2-negative Locally Advanced or Metastatic Breast Cancer TALZENNA is indicated as a single agent for the treatment of adult patients with deleterious or suspected delet
label id: b653221e-971f-4452-92d4-797924f1ff59
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start: 375

current approval status

not_reconciled

duplicate text group

dup-1d07af78174748355613

extraction review status

automated_candidate_pending_source_review

generic names

TALAZOPARIB

ind-span-56b9703e83f667403823

label id

b653221e-971f-4452-92d4-797924f1ff59

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 582
end exclusive: true
exact text: ( 1.2 )
label id: b653221e-971f-4452-92d4-797924f1ff59
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start: 575

source url

https://api.fda.gov/drug/label.json?search=id%3A%22b653221e-971f-4452-92d4-797924f1ff59%22

spl effective date

2024-07-09

spl set id

b653221e-971f-4452-92d4-797924f1ff59

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

Passage 7 · positive indication candidate

application numbers

NDA217439

brand names

Talzenna

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: 1162
end exclusive: true
exact text: TALZENNA. ( 1.1 ) HRR Gene-Mutated mCRPC • In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). ( 1.2 ) 1.1 BRCA -mutated (g BRCA m) HER2-negative Locally Advanced or Metastatic Breast Cancer TALZENNA is indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene ( BRCA )-mutated (g BRCA m) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA [see Dosage and Administration (2.1) ] . 1.2 HRR Gene-mutated mCRPC TALZENNA is indicated in combination with en
label id: b653221e-971f-4452-92d4-797924f1ff59
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start: 383

current approval status

not_reconciled

duplicate text group

dup-8319850b886330cdd226

extraction review status

automated_candidate_pending_source_review

generic names

TALAZOPARIB

ind-span-a8c113b4ef8eeb3a5fff

label id

b653221e-971f-4452-92d4-797924f1ff59

positive predicate support span

end: 692
end exclusive: true
exact text: is indicated
label id: b653221e-971f-4452-92d4-797924f1ff59
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start: 680

qualifier mentions

context exact
ALZENNA is indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline breast c
kind
age
polarity
not_inferred
span
end
746
end exclusive
true
exact text
adult patients
label id
b653221e-971f-4452-92d4-797924f1ff59
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start
732
context exact
1.1 BRCA -mutated (g BRCA m) HER2-negative Locally Advanced or Metastatic Breast Cancer TALZENNA is indicate
kind
biomarker
polarity
not_inferred
span
end
631
end exclusive
true
exact text
BRCA -mutated (g BRCA m) HER2-negative Local
label id
b653221e-971f-4452-92d4-797924f1ff59
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start
587
context exact
BRCA -mutated (g BRCA m) HER2-negative Locally Advanced or Metastatic Breast Cancer TALZENNA is indicated as a single agent for the treatment of adult patients wi
kind
biomarker
polarity
not_inferred
span
end
689
end exclusive
true
exact text
Metastatic Breast Cancer TALZENNA is indica
label id
b653221e-971f-4452-92d4-797924f1ff59
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start
646
context exact
ed deleterious germline breast cancer susceptibility gene ( BRCA )-mutated (g BRCA m) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or m
kind
biomarker
polarity
not_inferred
span
end
878
end exclusive
true
exact text
BRCA )-mutated (g BRCA m) human epidermal gr
label id
b653221e-971f-4452-92d4-797924f1ff59
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start
834
context exact
utated (g BRCA m) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer.
kind
biomarker
polarity
not_inferred
span
end
946
end exclusive
true
exact text
HER2)-negative locally advanced or metastati
label id
b653221e-971f-4452-92d4-797924f1ff59
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start
902
context exact
1.1 BRCA -mutated (g BRCA m) HER2-negative Locally Advanced or Metastatic Breast Cancer TALZENNA is indicated as a single agent for the treatment of adult
kind
stage_or_setting
polarity
not_inferred
span
end
677
end exclusive
true
exact text
Locally Advanced or Metastatic Breast Cancer TALZEN
label id
b653221e-971f-4452-92d4-797924f1ff59
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start
626
context exact
m) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer.
kind
stage_or_setting
polarity
not_inferred
span
end
961
end exclusive
true
exact text
locally advanced or metastatic breast cancer
label id
b653221e-971f-4452-92d4-797924f1ff59
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start
917
context exact
Advanced or Metastatic Breast Cancer TALZENNA is indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene ( BRCA )-mutated (g BRCA m) human epidermal growth factor receptor 2 (HER2)-negative locally advan
kind
regimen
polarity
not_inferred
span
end
870
end exclusive
true
exact text
as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene ( BRCA )-mutated (g BRCA m) human epid
label id
b653221e-971f-4452-92d4-797924f1ff59
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start
693

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 962
end exclusive: true
exact text: 1.1 BRCA -mutated (g BRCA m) HER2-negative Locally Advanced or Metastatic Breast Cancer TALZENNA is indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene ( BRCA )-mutated (g BRCA m) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer.
label id: b653221e-971f-4452-92d4-797924f1ff59
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start: 583

source url

https://api.fda.gov/drug/label.json?search=id%3A%22b653221e-971f-4452-92d4-797924f1ff59%22

spl effective date

2024-07-09

spl set id

b653221e-971f-4452-92d4-797924f1ff59

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 8 · unclassified context

application numbers

NDA217439

brand names

Talzenna

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1290
end exclusive: true
exact text: or suspected deleterious germline breast cancer susceptibility gene ( BRCA )-mutated (g BRCA m) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA [see Dosage and Administration (2.1) ] . 1.2 HRR Gene-mutated mCRPC TALZENNA is indicated in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-res
label id: b653221e-971f-4452-92d4-797924f1ff59
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start: 763

current approval status

not_reconciled

duplicate text group

dup-5cec3aa48ffa33352ace

extraction review status

automated_candidate_pending_source_review

generic names

TALAZOPARIB

ind-span-2f26ef4ac056ede98385

label id

b653221e-971f-4452-92d4-797924f1ff59

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 1090
end exclusive: true
exact text: Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA [see Dosage and Administration (2.1) ] .
label id: b653221e-971f-4452-92d4-797924f1ff59
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start: 963

source url

https://api.fda.gov/drug/label.json?search=id%3A%22b653221e-971f-4452-92d4-797924f1ff59%22

spl effective date

2024-07-09

spl set id

b653221e-971f-4452-92d4-797924f1ff59

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

Passage 9 · positive indication candidate

application numbers

NDA217439

brand names

Talzenna

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: 1361
end exclusive: true
exact text: eceptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA [see Dosage and Administration (2.1) ] . 1.2 HRR Gene-mutated mCRPC TALZENNA is indicated in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) [see Dosage and Administration (2.3) ] .
label id: b653221e-971f-4452-92d4-797924f1ff59
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start: 891

current approval status

not_reconciled

duplicate text group

dup-a53d3e2c4c778ba588d4

extraction review status

automated_candidate_pending_source_review

generic names

TALAZOPARIB

ind-span-2d88c421c85cb300f3eb

label id

b653221e-971f-4452-92d4-797924f1ff59

positive predicate support span

end: 1139
end exclusive: true
exact text: is indicated
label id: b653221e-971f-4452-92d4-797924f1ff59
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start: 1127

qualifier mentions

context exact
cated in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated met
kind
age
polarity
not_inferred
span
end
1208
end exclusive
true
exact text
adult patients
label id
b653221e-971f-4452-92d4-797924f1ff59
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start
1194
context exact
nts with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) [see Dosage and Administration (2.3) ] .
kind
biomarker
polarity
not_inferred
span
end
1308
end exclusive
true
exact text
metastatic castration-resistant prostate ca
label id
b653221e-971f-4452-92d4-797924f1ff59
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start
1265
context exact
nts with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) [see Dosage and Administration (2.3) ] .
kind
stage_or_setting
polarity
not_inferred
span
end
1310
end exclusive
true
exact text
metastatic castration-resistant prostate canc
label id
b653221e-971f-4452-92d4-797924f1ff59
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start
1265
context exact
1.2 HRR Gene-mutated mCRPC TALZENNA is indicated in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) [see Dosage and Administration (2.3) ] .
kind
regimen
polarity
not_inferred
span
end
1319
end exclusive
true
exact text
in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC
label id
b653221e-971f-4452-92d4-797924f1ff59
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start
1140

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 1361
end exclusive: true
exact text: 1.2 HRR Gene-mutated mCRPC TALZENNA is indicated in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) [see Dosage and Administration (2.3) ] .
label id: b653221e-971f-4452-92d4-797924f1ff59
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 62f1197b47f1f25c63bbda386527aef3f88bc8e8a985ce80ea8528da351382be
start: 1091

source url

https://api.fda.gov/drug/label.json?search=id%3A%22b653221e-971f-4452-92d4-797924f1ff59%22

spl effective date

2024-07-09

spl set id

b653221e-971f-4452-92d4-797924f1ff59

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

Preserved source evidence · Not medical advice