LABELS · 42b97c44-15f5-4d38-b382-bbc1b2e654d0

AVGEMSI

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2026-07-27
Captured: 2026-09-09T23:37:44.904352+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE AVGEMSI is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ( 1.1 ) in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. ( 1.2 ) in combination with cisplatin, for the treatment of non-small cell lung cancer. ( 1.3 ) as a single agent for the treatment of pancreatic cancer. ( 1.4 ) 1.1 Ovarian Cancer AVGEMSI in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. 1.2 Breast Cancer AVGEMSI in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. 1.3 Non-Small Cell Lung Cancer AVGEMSI in combination with cisplatin is indicated for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC). 1.4 Pancreatic Cancer AVGEMSI is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. AVGEMSI is indicated for patients previously treated with fluorouracil.

Full extracted label fields

application numbers

NDA219920

boxed warning exact

brand names

AVGEMSI

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e11eeff7-bcaf-4bf1-8da8-88138e01af84

generic names

GEMCITABINE

42b97c44-15f5-4d38-b382-bbc1b2e654d0

indications and usage exact

1 INDICATIONS AND USAGE AVGEMSI is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ( 1.1 ) in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. ( 1.2 ) in combination with cisplatin, for the treatment of non-small cell lung cancer. ( 1.3 ) as a single agent for the treatment of pancreatic cancer. ( 1.4 ) 1.1 Ovarian Cancer AVGEMSI in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. 1.2 Breast Cancer AVGEMSI in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. 1.3 Non-Small Cell Lung Cancer AVGEMSI in combination with cisplatin is indicated for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC). 1.4 Pancreatic Cancer AVGEMSI is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. AVGEMSI is indicated for patients previously treated with fluorouracil.

indications and usage tables exact

is original packager

true

manufacturer names

Avyxa Pharma, LLC

matched search terms

cancer

package ndcs

83831-122-01
83831-123-01
83831-124-01

product ndcs

83831-123
83831-122
83831-124

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS

rxcuis

2719761
2719763

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00200.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

NDA219920

brand names

AVGEMSI

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: 436
end exclusive: true
exact text: 1 INDICATIONS AND USAGE AVGEMSI is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ( 1.1 ) in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinical
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source text sha256: 9e725307a889e8b2dc6d0a7e2cfe45ace7b399b9f840dd5c9718d1b38cae1045
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current approval status

not_reconciled

duplicate text group

dup-bf0c50cb002f5abc1e35

extraction review status

automated_candidate_pending_source_review

generic names

GEMCITABINE

ind-span-19b6a236c4922444531b

label id

42b97c44-15f5-4d38-b382-bbc1b2e654d0

positive predicate support span

end: 77
end exclusive: true
exact text: is a nucleoside metabolic inhibitor indicated
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source field: indications_and_usage_exact
source text sha256: 9e725307a889e8b2dc6d0a7e2cfe45ace7b399b9f840dd5c9718d1b38cae1045
start: 32

qualifier mentions

context exact
1 INDICATIONS AND USAGE AVGEMSI is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian c
kind
biomarker
polarity
not_inferred
span
end
91
end exclusive
true
exact text
metabolic inhibitor indicated: in combinati
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source field
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source text sha256
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context exact
ated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
kind
stage_or_setting
polarity
not_inferred
span
end
176
end exclusive
true
exact text
advanced ovarian cancer that has relapsed a
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source array index
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source field
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source text sha256
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context exact
SAGE AVGEMSI is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
kind
regimen
polarity
not_inferred
span
end
235
end exclusive
true
exact text
in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy
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source array index
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source field
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source text sha256
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regulatory links

schema version

0.1.0

source batch sha256

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source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
1333
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
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source field
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source text sha256
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source span

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end exclusive: true
exact text: 1 INDICATIONS AND USAGE AVGEMSI is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
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source array index: 0
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source text sha256: 9e725307a889e8b2dc6d0a7e2cfe45ace7b399b9f840dd5c9718d1b38cae1045
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%2242b97c44-15f5-4d38-b382-bbc1b2e654d0%22

spl effective date

2026-07-27

spl set id

e11eeff7-bcaf-4bf1-8da8-88138e01af84

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

tumor_directed_candidate

Passage 2 · unclassified context

application numbers

NDA219920

brand names

AVGEMSI

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 444
end exclusive: true
exact text: nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ( 1.1 ) in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contr
label id: 42b97c44-15f5-4d38-b382-bbc1b2e654d0
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9e725307a889e8b2dc6d0a7e2cfe45ace7b399b9f840dd5c9718d1b38cae1045
start: 37

current approval status

not_reconciled

duplicate text group

dup-2f5dd4b166d7f97e4190

extraction review status

automated_candidate_pending_source_review

generic names

GEMCITABINE

ind-span-5d7d50d713c809fcc9fa

label id

42b97c44-15f5-4d38-b382-bbc1b2e654d0

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
1333
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
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source field
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source text sha256
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source span

end: 244
end exclusive: true
exact text: ( 1.1 )
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offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9e725307a889e8b2dc6d0a7e2cfe45ace7b399b9f840dd5c9718d1b38cae1045
start: 237

source url

https://api.fda.gov/drug/label.json?search=id%3A%2242b97c44-15f5-4d38-b382-bbc1b2e654d0%22

spl effective date

2026-07-27

spl set id

e11eeff7-bcaf-4bf1-8da8-88138e01af84

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 · risk or warning

application numbers

NDA219920

brand names

AVGEMSI

classification reasons

risk_or_warning_words_without_positive_predicate

clinical review status

pending

content role

risk_or_warning

context span

end: 655
end exclusive: true
exact text: de metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ( 1.1 ) in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. ( 1.2 ) in combination with cisplatin, for the treatment of non-small cell lung cancer. ( 1.3 ) as a single agent for the treatment of pancreatic cancer. ( 1.4 ) 1.1 Ovarian Cancer AVGEMSI in combina
label id: 42b97c44-15f5-4d38-b382-bbc1b2e654d0
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9e725307a889e8b2dc6d0a7e2cfe45ace7b399b9f840dd5c9718d1b38cae1045
start: 45

current approval status

not_reconciled

duplicate text group

dup-dac7399300c20e19ecc8

extraction review status

automated_candidate_pending_source_review

generic names

GEMCITABINE

ind-span-459218b4689930323803

label id

42b97c44-15f5-4d38-b382-bbc1b2e654d0

positive predicate support span

Source null

qualifier mentions

context exact
in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless
kind
biomarker
polarity
not_inferred
span
end
348
end exclusive
true
exact text
metastatic breast cancer after failure of p
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source array index
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source field
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source text sha256
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start
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context exact
in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless an
kind
stage_or_setting
polarity
not_inferred
span
end
350
end exclusive
true
exact text
metastatic breast cancer after failure of pri
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offset unit
unicode_code_points
source array index
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source field
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source text sha256
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start
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context exact
east cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
kind
stage_or_setting
polarity
not_inferred
span
end
399
end exclusive
true
exact text
adjuvant chemotherapy
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source text sha256
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context exact
in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
kind
prior_therapy_or_line
polarity
not_inferred
span
end
451
end exclusive
true
exact text
first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindica
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source text sha256
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start
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context exact
in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
kind
regimen
polarity
not_inferred
span
end
424
end exclusive
true
exact text
in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines w
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source text sha256
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regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
1333
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
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source span

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end exclusive: true
exact text: in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
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offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9e725307a889e8b2dc6d0a7e2cfe45ace7b399b9f840dd5c9718d1b38cae1045
start: 245

source url

https://api.fda.gov/drug/label.json?search=id%3A%2242b97c44-15f5-4d38-b382-bbc1b2e654d0%22

spl effective date

2026-07-27

spl set id

e11eeff7-bcaf-4bf1-8da8-88138e01af84

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 4 · unclassified context

application numbers

NDA219920

brand names

AVGEMSI

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

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end exclusive: true
exact text: ion with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. ( 1.2 ) in combination with cisplatin, for the treatment of non-small cell lung cancer. ( 1.3 ) as a single agent for the treatment of pancreatic cancer. ( 1.4 ) 1.1 Ovarian Cancer AVGEMSI in combination wit
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offset unit: unicode_code_points
source array index: 0
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source text sha256: 9e725307a889e8b2dc6d0a7e2cfe45ace7b399b9f840dd5c9718d1b38cae1045
start: 256

current approval status

not_reconciled

duplicate text group

dup-efae6b8421e9b3910f89

extraction review status

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generic names

GEMCITABINE

ind-span-cbeb0ef796ffb5a55c5b

label id

42b97c44-15f5-4d38-b382-bbc1b2e654d0

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

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source batch sha256

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source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
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end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
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source text sha256
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source span

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exact text: ( 1.2 )
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source text sha256: 9e725307a889e8b2dc6d0a7e2cfe45ace7b399b9f840dd5c9718d1b38cae1045
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source url

https://api.fda.gov/drug/label.json?search=id%3A%2242b97c44-15f5-4d38-b382-bbc1b2e654d0%22

spl effective date

2026-07-27

spl set id

e11eeff7-bcaf-4bf1-8da8-88138e01af84

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 · unclassified context

application numbers

NDA219920

brand names

AVGEMSI

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

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end exclusive: true
exact text: paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. ( 1.2 ) in combination with cisplatin, for the treatment of non-small cell lung cancer. ( 1.3 ) as a single agent for the treatment of pancreatic cancer. ( 1.4 ) 1.1 Ovarian Cancer AVGEMSI in combination with carboplatin is indicated for the treatment of patients with advanced ovarian c
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source array index: 0
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source text sha256: 9e725307a889e8b2dc6d0a7e2cfe45ace7b399b9f840dd5c9718d1b38cae1045
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current approval status

not_reconciled

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extraction review status

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generic names

GEMCITABINE

ind-span-17cc67089a085b509a95

label id

42b97c44-15f5-4d38-b382-bbc1b2e654d0

positive predicate support span

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qualifier mentions

context exact
in combination with cisplatin, for the treatment of non-small cell lung cancer.
kind
regimen
polarity
not_inferred
span
end
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end exclusive
true
exact text
in combination with cisplatin, for the treatment of non-small cell lung cancer
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regulatory links

schema version

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source defined aliases

abbreviation
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definition exact
non-small cell lung cancer
definition span
end
1333
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
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source span

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end exclusive: true
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exact text: in combination with cisplatin is indicated for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC). 1.4 Pancreatic Cancer AVGEMSI is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. AVGEMSI is indicated for patients previously treated with fluorouracil.
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exact text: ). 1.4 Pancreatic Cancer AVGEMSI is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. AVGEMSI is indicated for patients previously treated with fluorouracil.
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Preserved source evidence · Not medical advice