LABELS · 9541dd80-09f9-4d3c-bb2a-fc354e198a2e

FASLODEX

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: 2020-09-25
Captured: 2026-09-09T23:37:54.830918+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE Monotherapy FASLODEX is indicated for the treatment of: • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or • HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. Combination Therapy FASLODEX is indicated for the treatment of: • HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy. • HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. FASLODEX is an estrogen receptor antagonist indicated for the treatment of: • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy. (1) • HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. (1) • HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy. (1) • HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. (1)

Full extracted label fields

application numbers

NDA021344

boxed warning exact

brand names

FASLODEX

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=83d7a440-e904-4e36-afb5-cb02b1c919f7

generic names

FULVESTRANT

9541dd80-09f9-4d3c-bb2a-fc354e198a2e

indications and usage exact

1 INDICATIONS AND USAGE Monotherapy FASLODEX is indicated for the treatment of: • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or • HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. Combination Therapy FASLODEX is indicated for the treatment of: • HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy. • HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. FASLODEX is an estrogen receptor antagonist indicated for the treatment of: • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy. (1) • HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. (1) • HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy. (1) • HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. (1)

indications and usage tables exact

is original packager

true

manufacturer names

AstraZeneca Pharmaceuticals LP

matched search terms

cancer

package ndcs

0310-0720-10

product ndcs

0310-0720

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

INTRAMUSCULAR

rxcuis

727762
727954

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00500.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 · positive indication candidate

application numbers

NDA021344

brand names

FASLODEX

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 279
end exclusive: true
exact text: 1 INDICATIONS AND USAGE Monotherapy FASLODEX is indicated for the treatment of: • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or • HR-positi
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 0

current approval status

not_reconciled

duplicate text group

dup-13e4f41615bc1da3f3d7

extraction review status

automated_candidate_pending_source_review

generic names

FULVESTRANT

ind-span-e4688c9e35fbea92fdb5

label id

9541dd80-09f9-4d3c-bb2a-fc354e198a2e

positive predicate support span

end: 57
end exclusive: true
exact text: is indicated
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 45

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 79
end exclusive: true
exact text: 1 INDICATIONS AND USAGE Monotherapy FASLODEX is indicated for the treatment of:
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%229541dd80-09f9-4d3c-bb2a-fc354e198a2e%22

spl effective date

2020-09-25

spl set id

83d7a440-e904-4e36-afb5-cb02b1c919f7

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

non_oncology_or_unclear_candidate

Passage 2 · unclassified context

application numbers

NDA021344

brand names

FASLODEX

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 467
end exclusive: true
exact text: 1 INDICATIONS AND USAGE Monotherapy FASLODEX is indicated for the treatment of: • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or • HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. Combination Therapy FASLODEX is indicated for the treatment of: • HR-positive, HER2-
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 0

current approval status

not_reconciled

duplicate text group

dup-40cb24159f863b1791bc

extraction review status

automated_candidate_pending_source_review

generic names

FULVESTRANT

ind-span-25b7c0688892ae267883

label id

9541dd80-09f9-4d3c-bb2a-fc354e198a2e

positive predicate support span

Source null

qualifier mentions

context exact
or (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine ther
kind
biomarker
polarity
not_inferred
span
end
200
end exclusive
true
exact text
HER2)-negative advanced breast cancer in pos
label id
9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start
156
context exact
e, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or
kind
stage_or_setting
polarity
not_inferred
span
end
214
end exclusive
true
exact text
advanced breast cancer in postmenopausal wo
label id
9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start
171
context exact
negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or
kind
prior_therapy_or_line
polarity
not_inferred
span
end
267
end exclusive
true
exact text
previously treated with endocrine therapy, or
label id
9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start
222

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 267
end exclusive: true
exact text: • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 80

source url

https://api.fda.gov/drug/label.json?search=id%3A%229541dd80-09f9-4d3c-bb2a-fc354e198a2e%22

spl effective date

2020-09-25

spl set id

83d7a440-e904-4e36-afb5-cb02b1c919f7

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 3 · unclassified context

application numbers

NDA021344

brand names

FASLODEX

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 582
end exclusive: true
exact text: eatment of: • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or • HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. Combination Therapy FASLODEX is indicated for the treatment of: • HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial end
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 68

current approval status

not_reconciled

duplicate text group

dup-409aac9616e675b3055d

extraction review status

automated_candidate_pending_source_review

generic names

FULVESTRANT

ind-span-dec0880632d591f8728f

label id

9541dd80-09f9-4d3c-bb2a-fc354e198a2e

positive predicate support span

Source null

qualifier mentions

context exact
• HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.
kind
stage_or_setting
polarity
not_inferred
span
end
325
end exclusive
true
exact text
advanced breast cancer in postmenopausal wo
label id
9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start
282

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 382
end exclusive: true
exact text: • HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 268

source url

https://api.fda.gov/drug/label.json?search=id%3A%229541dd80-09f9-4d3c-bb2a-fc354e198a2e%22

spl effective date

2020-09-25

spl set id

83d7a440-e904-4e36-afb5-cb02b1c919f7

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 · positive indication candidate

application numbers

NDA021344

brand names

FASLODEX

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 646
end exclusive: true
exact text: ast cancer in postmenopausal women not previously treated with endocrine therapy, or • HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. Combination Therapy FASLODEX is indicated for the treatment of: • HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocri
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 183

current approval status

not_reconciled

duplicate text group

dup-3730f218e8ed3747eb91

extraction review status

automated_candidate_pending_source_review

generic names

FULVESTRANT

ind-span-9c8fc89527458735c2c6

label id

9541dd80-09f9-4d3c-bb2a-fc354e198a2e

positive predicate support span

end: 424
end exclusive: true
exact text: is indicated
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 412

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 446
end exclusive: true
exact text: Combination Therapy FASLODEX is indicated for the treatment of:
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 383

source url

https://api.fda.gov/drug/label.json?search=id%3A%229541dd80-09f9-4d3c-bb2a-fc354e198a2e%22

spl effective date

2020-09-25

spl set id

83d7a440-e904-4e36-afb5-cb02b1c919f7

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

non_oncology_or_unclear_candidate

Passage 5 · positive indication candidate

application numbers

NDA021344

brand names

FASLODEX

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: 857
end exclusive: true
exact text: ndocrine therapy, or • HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. Combination Therapy FASLODEX is indicated for the treatment of: • HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy. • HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. FASLODEX is an estrogen rec
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 247

current approval status

not_reconciled

duplicate text group

dup-89789902ed9d15b7dfba

extraction review status

automated_candidate_pending_source_review

generic names

FULVESTRANT

ind-span-8ab5f0648625b9d88959

label id

9541dd80-09f9-4d3c-bb2a-fc354e198a2e

positive predicate support span

end: 424
end exclusive: true
exact text: is indicated
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 412

qualifier mentions

context exact
• HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribocicli
kind
biomarker
polarity
not_inferred
span
end
506
end exclusive
true
exact text
HER2-negative advanced or metastatic breast
label id
9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start
462
context exact
• HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial
kind
stage_or_setting
polarity
not_inferred
span
end
519
end exclusive
true
exact text
advanced or metastatic breast cancer in pos
label id
9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start
476
context exact
dvanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy.
kind
regimen
polarity
not_inferred
span
end
656
end exclusive
true
exact text
in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy
label id
9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start
537

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 657
end exclusive: true
exact text: • HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy.
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 447

source url

https://api.fda.gov/drug/label.json?search=id%3A%229541dd80-09f9-4d3c-bb2a-fc354e198a2e%22

spl effective date

2020-09-25

spl set id

83d7a440-e904-4e36-afb5-cb02b1c919f7

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 · positive indication candidate

application numbers

NDA021344

brand names

FASLODEX

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: 1029
end exclusive: true
exact text: ve, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy. • HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. FASLODEX is an estrogen receptor antagonist indicated for the treatment of: • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postme
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 458

current approval status

not_reconciled

duplicate text group

dup-5b84b16580896d66414f

extraction review status

automated_candidate_pending_source_review

generic names

FULVESTRANT

ind-span-0cc6d74791d1cf41adc8

label id

9541dd80-09f9-4d3c-bb2a-fc354e198a2e

positive predicate support span

end: 424
end exclusive: true
exact text: is indicated
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 412

qualifier mentions

context exact
• HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in wom
kind
biomarker
polarity
not_inferred
span
end
717
end exclusive
true
exact text
HER2-negative advanced or metastatic breast
label id
9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start
673
context exact
• HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disea
kind
stage_or_setting
polarity
not_inferred
span
end
730
end exclusive
true
exact text
advanced or metastatic breast cancer in com
label id
9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start
687
context exact
ositive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.
kind
regimen
polarity
not_inferred
span
end
828
end exclusive
true
exact text
in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy
label id
9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start
724

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 829
end exclusive: true
exact text: • HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 658

source url

https://api.fda.gov/drug/label.json?search=id%3A%229541dd80-09f9-4d3c-bb2a-fc354e198a2e%22

spl effective date

2020-09-25

spl set id

83d7a440-e904-4e36-afb5-cb02b1c919f7

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 7 · positive indication candidate

application numbers

NDA021344

brand names

FASLODEX

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1105
end exclusive: true
exact text: ssion on endocrine therapy. • HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. FASLODEX is an estrogen receptor antagonist indicated for the treatment of: • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy. (1) • HR-posit
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 630

current approval status

not_reconciled

duplicate text group

dup-fe11133de7c7b066a94c

extraction review status

automated_candidate_pending_source_review

generic names

FULVESTRANT

ind-span-fb00e1b7a14dcec1ad56

label id

9541dd80-09f9-4d3c-bb2a-fc354e198a2e

positive predicate support span

end: 883
end exclusive: true
exact text: is an estrogen receptor antagonist indicated
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 839

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 905
end exclusive: true
exact text: FASLODEX is an estrogen receptor antagonist indicated for the treatment of:
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 830

source url

https://api.fda.gov/drug/label.json?search=id%3A%229541dd80-09f9-4d3c-bb2a-fc354e198a2e%22

spl effective date

2020-09-25

spl set id

83d7a440-e904-4e36-afb5-cb02b1c919f7

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

non_oncology_or_unclear_candidate

Passage 8 · unclassified context

application numbers

NDA021344

brand names

FASLODEX

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1290
end exclusive: true
exact text: tic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. FASLODEX is an estrogen receptor antagonist indicated for the treatment of: • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy. (1) • HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. (1) • HR-positive, HER2-negative advanced or metastatic breast cancer in postmen
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 706

current approval status

not_reconciled

duplicate text group

dup-7fa3d21e9d58a2a7978f

extraction review status

automated_candidate_pending_source_review

generic names

FULVESTRANT

ind-span-7004fe4a1b2b2e057a71

label id

9541dd80-09f9-4d3c-bb2a-fc354e198a2e

positive predicate support span

Source null

qualifier mentions

context exact
or (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine ther
kind
biomarker
polarity
not_inferred
span
end
1026
end exclusive
true
exact text
HER2)-negative advanced breast cancer in pos
label id
9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start
982
context exact
e, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy.
kind
stage_or_setting
polarity
not_inferred
span
end
1040
end exclusive
true
exact text
advanced breast cancer in postmenopausal wo
label id
9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start
997
context exact
negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy.
kind
prior_therapy_or_line
polarity
not_inferred
span
end
1089
end exclusive
true
exact text
previously treated with endocrine therapy
label id
9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start
1048

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 1090
end exclusive: true
exact text: • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy.
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 906

source url

https://api.fda.gov/drug/label.json?search=id%3A%229541dd80-09f9-4d3c-bb2a-fc354e198a2e%22

spl effective date

2020-09-25

spl set id

83d7a440-e904-4e36-afb5-cb02b1c919f7

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 · unclassified context

application numbers

NDA021344

brand names

FASLODEX

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1294
end exclusive: true
exact text: treatment of: • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy. (1) • HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. (1) • HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopau
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 891

current approval status

not_reconciled

duplicate text group

dup-5d1500c3bda674b0cc01

extraction review status

automated_candidate_pending_source_review

generic names

FULVESTRANT

ind-span-207e5c722d5d077f7705

label id

9541dd80-09f9-4d3c-bb2a-fc354e198a2e

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 1094
end exclusive: true
exact text: (1)
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 1091

source url

https://api.fda.gov/drug/label.json?search=id%3A%229541dd80-09f9-4d3c-bb2a-fc354e198a2e%22

spl effective date

2020-09-25

spl set id

83d7a440-e904-4e36-afb5-cb02b1c919f7

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 10 · unclassified context

application numbers

NDA021344

brand names

FASLODEX

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1409
end exclusive: true
exact text: atment of: • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy. (1) • HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. (1) • HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on en
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 895

current approval status

not_reconciled

duplicate text group

dup-409aac9616e675b3055d

extraction review status

automated_candidate_pending_source_review

generic names

FULVESTRANT

ind-span-22f45bd4cb5e6a8cc5f4

label id

9541dd80-09f9-4d3c-bb2a-fc354e198a2e

positive predicate support span

Source null

qualifier mentions

context exact
• HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.
kind
stage_or_setting
polarity
not_inferred
span
end
1152
end exclusive
true
exact text
advanced breast cancer in postmenopausal wo
label id
9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start
1109

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 1209
end exclusive: true
exact text: • HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 1095

source url

https://api.fda.gov/drug/label.json?search=id%3A%229541dd80-09f9-4d3c-bb2a-fc354e198a2e%22

spl effective date

2020-09-25

spl set id

83d7a440-e904-4e36-afb5-cb02b1c919f7

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 11 · unclassified context

application numbers

NDA021344

brand names

FASLODEX

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1413
end exclusive: true
exact text: st cancer in postmenopausal women not previously treated with endocrine therapy. (1) • HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. (1) • HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocr
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 1010

current approval status

not_reconciled

duplicate text group

dup-5d1500c3bda674b0cc01

extraction review status

automated_candidate_pending_source_review

generic names

FULVESTRANT

ind-span-f6151921f25a68982dd3

label id

9541dd80-09f9-4d3c-bb2a-fc354e198a2e

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 1213
end exclusive: true
exact text: (1)
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 1210

source url

https://api.fda.gov/drug/label.json?search=id%3A%229541dd80-09f9-4d3c-bb2a-fc354e198a2e%22

spl effective date

2020-09-25

spl set id

83d7a440-e904-4e36-afb5-cb02b1c919f7

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 12 · positive indication candidate

application numbers

NDA021344

brand names

FASLODEX

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: 1605
end exclusive: true
exact text: ancer in postmenopausal women not previously treated with endocrine therapy. (1) • HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. (1) • HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy. (1) • HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. (1)
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 1014

current approval status

not_reconciled

duplicate text group

dup-89789902ed9d15b7dfba

extraction review status

automated_candidate_pending_source_review

generic names

FULVESTRANT

ind-span-ed01ac8c0dcca397bdc5

label id

9541dd80-09f9-4d3c-bb2a-fc354e198a2e

positive predicate support span

end: 883
end exclusive: true
exact text: is an estrogen receptor antagonist indicated
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 839

qualifier mentions

context exact
• HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribocicli
kind
biomarker
polarity
not_inferred
span
end
1273
end exclusive
true
exact text
HER2-negative advanced or metastatic breast
label id
9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start
1229
context exact
• HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial
kind
stage_or_setting
polarity
not_inferred
span
end
1286
end exclusive
true
exact text
advanced or metastatic breast cancer in pos
label id
9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start
1243
context exact
dvanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy.
kind
regimen
polarity
not_inferred
span
end
1424
end exclusive
true
exact text
in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy
label id
9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start
1304

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 1425
end exclusive: true
exact text: • HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy.
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 1214

source url

https://api.fda.gov/drug/label.json?search=id%3A%229541dd80-09f9-4d3c-bb2a-fc354e198a2e%22

spl effective date

2020-09-25

spl set id

83d7a440-e904-4e36-afb5-cb02b1c919f7

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 13 · unclassified context

application numbers

NDA021344

brand names

FASLODEX

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1605
end exclusive: true
exact text: e, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy. (1) • HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. (1)
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 1226

current approval status

not_reconciled

duplicate text group

dup-5d1500c3bda674b0cc01

extraction review status

automated_candidate_pending_source_review

generic names

FULVESTRANT

ind-span-be0c78b9210f4b6e5b13

label id

9541dd80-09f9-4d3c-bb2a-fc354e198a2e

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 1429
end exclusive: true
exact text: (1)
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 1426

source url

https://api.fda.gov/drug/label.json?search=id%3A%229541dd80-09f9-4d3c-bb2a-fc354e198a2e%22

spl effective date

2020-09-25

spl set id

83d7a440-e904-4e36-afb5-cb02b1c919f7

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 14 · positive indication candidate

application numbers

NDA021344

brand names

FASLODEX

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: 1605
end exclusive: true
exact text: ER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy. (1) • HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. (1)
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 1230

current approval status

not_reconciled

duplicate text group

dup-5b84b16580896d66414f

extraction review status

automated_candidate_pending_source_review

generic names

FULVESTRANT

ind-span-7c34fb25a91a3e2df97a

label id

9541dd80-09f9-4d3c-bb2a-fc354e198a2e

positive predicate support span

end: 883
end exclusive: true
exact text: is an estrogen receptor antagonist indicated
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 839

qualifier mentions

context exact
• HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in wom
kind
biomarker
polarity
not_inferred
span
end
1489
end exclusive
true
exact text
HER2-negative advanced or metastatic breast
label id
9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start
1445
context exact
• HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disea
kind
stage_or_setting
polarity
not_inferred
span
end
1502
end exclusive
true
exact text
advanced or metastatic breast cancer in com
label id
9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start
1459
context exact
ositive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.
kind
regimen
polarity
not_inferred
span
end
1600
end exclusive
true
exact text
in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy
label id
9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start
1496

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 1601
end exclusive: true
exact text: • HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 1430

source url

https://api.fda.gov/drug/label.json?search=id%3A%229541dd80-09f9-4d3c-bb2a-fc354e198a2e%22

spl effective date

2020-09-25

spl set id

83d7a440-e904-4e36-afb5-cb02b1c919f7

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 15 · unclassified context

application numbers

NDA021344

brand names

FASLODEX

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1605
end exclusive: true
exact text: n on endocrine therapy. (1) • HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. (1)
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 1402

current approval status

not_reconciled

duplicate text group

dup-5d1500c3bda674b0cc01

extraction review status

automated_candidate_pending_source_review

generic names

FULVESTRANT

ind-span-7e0fe4ecc6a603661c91

label id

9541dd80-09f9-4d3c-bb2a-fc354e198a2e

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 1605
end exclusive: true
exact text: (1)
label id: 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 14dd1fec581d970221c6c049e2cf5c1864f49696110ab179a572706033e0bbe4
start: 1602

source url

https://api.fda.gov/drug/label.json?search=id%3A%229541dd80-09f9-4d3c-bb2a-fc354e198a2e%22

spl effective date

2020-09-25

spl set id

83d7a440-e904-4e36-afb5-cb02b1c919f7

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