LABELS · 49f6182a-5e0f-45ea-8a0f-b774ef28a98f

HERZUMA

Open original source → · Download preserved record

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

Label effective date: 2025-12-22
Captured: 2026-09-09T23:37:44.904352+00:00
Current indication reconciliation: Not reconciled

Boxed warning in this label

WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY See full prescribing information for complete boxed warning Cardiomyopathy: Trastuzumab products can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue HERZUMA for cardiomyopathy. ( 2.5 , 5.1 ) Infusion Reactions, Pulmonary Toxicity: Discontinue HERZUMA for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. ( 5.2 , 5.4 ) Embryo-Fetal Toxicity: Exposure to trastuzumab products during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception. ( 5.3 , 8.1 , 8.3 ) Cardiomyopathy Administration of trastuzumab products can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens. Evaluate left ventricular function in all patients prior to and during treatment with HERZUMA. Discontinue HERZUMA treatment in patients receiving adjuvant therapy and withhold HERZUMA in patients with metastatic disease for clinically significant decrease in left ventricular function [see Dosage and Administration ( 2.5 ) and Warnings and Precautions (5.1) ] . Infusion Reactions; Pulmonary Toxicity Administration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration of trastuzumab products. Interrupt HERZUMA infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue HERZUMA for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome [see Warnings and Precautions (5.2 , 5.4) ] . Embryo-Fetal Toxicity Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1 , 8.3) ] .

Indications and usage: exact source text

1 INDICATIONS AND USAGE HERZUMA is a HER2/neu receptor antagonist indicated in adults for: the treatment of HER2-overexpressing breast cancer. ( 1.1 , 1.2 ) the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. ( 1.3 ) Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product. ( 1 , 2.2 ) 1.1 Adjuvant Breast Cancer HERZUMA is indicated in adults for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies (14.1) ] ) breast cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel as part of a treatment regimen with docetaxel and carboplatin as a single agent following multi-modality anthracycline based therapy Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2) ] . 1.2 Metastatic Breast Cancer HERZUMA is indicated in adults: In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2) ] . 1.3 Metastatic Gastric Cancer HERZUMA is indicated in adults, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2) ] .

Full extracted label fields

application numbers

BLA761091

boxed warning exact

WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY See full prescribing information for complete boxed warning Cardiomyopathy: Trastuzumab products can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue HERZUMA for cardiomyopathy. ( 2.5 , 5.1 ) Infusion Reactions, Pulmonary Toxicity: Discontinue HERZUMA for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. ( 5.2 , 5.4 ) Embryo-Fetal Toxicity: Exposure to trastuzumab products during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception. ( 5.3 , 8.1 , 8.3 ) Cardiomyopathy Administration of trastuzumab products can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens. Evaluate left ventricular function in all patients prior to and during treatment with HERZUMA. Discontinue HERZUMA treatment in patients receiving adjuvant therapy and withhold HERZUMA in patients with metastatic disease for clinically significant decrease in left ventricular function [see Dosage and Administration ( 2.5 ) and Warnings and Precautions (5.1) ] . Infusion Reactions; Pulmonary Toxicity Administration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration of trastuzumab products. Interrupt HERZUMA infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue HERZUMA for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome [see Warnings and Precautions (5.2 , 5.4) ] . Embryo-Fetal Toxicity Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1 , 8.3) ] .

brand names

HERZUMA

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ae71c003-883a-4cd8-ad50-e8cc9a54e971

generic names

TRASTUZUMAB

49f6182a-5e0f-45ea-8a0f-b774ef28a98f

indications and usage exact

1 INDICATIONS AND USAGE HERZUMA is a HER2/neu receptor antagonist indicated in adults for: the treatment of HER2-overexpressing breast cancer. ( 1.1 , 1.2 ) the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. ( 1.3 ) Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product. ( 1 , 2.2 ) 1.1 Adjuvant Breast Cancer HERZUMA is indicated in adults for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies (14.1) ] ) breast cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel as part of a treatment regimen with docetaxel and carboplatin as a single agent following multi-modality anthracycline based therapy Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2) ] . 1.2 Metastatic Breast Cancer HERZUMA is indicated in adults: In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2) ] . 1.3 Metastatic Gastric Cancer HERZUMA is indicated in adults, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2) ] .

indications and usage tables exact

is original packager

true

manufacturer names

Cephalon, Inc.

matched search terms

cancer

package ndcs

63459-305-47
63459-307-41
63459-221-20
63459-303-43

product ndcs

63459-303
63459-305

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Dosage and Administration, Evaluation and Testing Before Initiating HERZUMA ( 2.1 ) 11/2024

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS

rxcuis

2107053
2107058
2169359
2169362

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

BLA761091

brand names

HERZUMA

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: 342
end exclusive: true
exact text: 1 INDICATIONS AND USAGE HERZUMA is a HER2/neu receptor antagonist indicated in adults for: the treatment of HER2-overexpressing breast cancer. ( 1.1 , 1.2 ) the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. ( 1.3 ) Select patients for therapy based on an FDA-approved companion diagnostic fo
label id: 49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start: 0

current approval status

not_reconciled

duplicate text group

dup-a8cb200ccfabc3e4bd22

extraction review status

automated_candidate_pending_source_review

generic names

TRASTUZUMAB

ind-span-709bbe59e3be1070ad5c

label id

49f6182a-5e0f-45ea-8a0f-b774ef28a98f

positive predicate support span

end: 75
end exclusive: true
exact text: is a HER2/neu receptor antagonist indicated
label id: 49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start: 32

qualifier mentions

context exact
SAGE HERZUMA is a HER2/neu receptor antagonist indicated in adults for: the treatment of HER2-overexpressing breast cancer.
kind
age
polarity
not_inferred
span
end
85
end exclusive
true
exact text
adults
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
79
context exact
1 INDICATIONS AND USAGE HERZUMA is a HER2/neu receptor antagonist indicated in adults for: the treatment of HER2-overexpressing breast cancer
kind
biomarker
polarity
not_inferred
span
end
81
end exclusive
true
exact text
HER2/neu receptor antagonist indicated in ad
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
37
context exact
ceptor antagonist indicated in adults for: the treatment of HER2-overexpressing breast cancer.
kind
biomarker
polarity
not_inferred
span
end
141
end exclusive
true
exact text
HER2-overexpressing breast cancer
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
108

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 142
end exclusive: true
exact text: 1 INDICATIONS AND USAGE HERZUMA is a HER2/neu receptor antagonist indicated in adults for: the treatment of HER2-overexpressing breast cancer.
label id: 49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%2249f6182a-5e0f-45ea-8a0f-b774ef28a98f%22

spl effective date

2025-12-22

spl set id

ae71c003-883a-4cd8-ad50-e8cc9a54e971

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

BLA761091

brand names

HERZUMA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 457
end exclusive: true
exact text: 1 INDICATIONS AND USAGE HERZUMA is a HER2/neu receptor antagonist indicated in adults for: the treatment of HER2-overexpressing breast cancer. ( 1.1 , 1.2 ) the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. ( 1.3 ) Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product. ( 1 , 2.2 ) 1.1 Adjuvant Breast Cancer HERZUMA is indicated in adults for adjuvant treatme
label id: 49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start: 0

current approval status

not_reconciled

duplicate text group

dup-db09dd57eceea8daef55

extraction review status

automated_candidate_pending_source_review

generic names

TRASTUZUMAB

ind-span-9fcd4089e91c654f2901

label id

49f6182a-5e0f-45ea-8a0f-b774ef28a98f

positive predicate support span

Source null

qualifier mentions

context exact
( 1.1 , 1.2 ) the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
kind
biomarker
polarity
not_inferred
span
end
218
end exclusive
true
exact text
HER2-overexpressing metastatic gastric or ga
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
174
context exact
( 1.1 , 1.2 ) the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
kind
stage_or_setting
polarity
not_inferred
span
end
239
end exclusive
true
exact text
metastatic gastric or gastroesophageal juncti
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
194

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 257
end exclusive: true
exact text: ( 1.1 , 1.2 ) the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
label id: 49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start: 143

source url

https://api.fda.gov/drug/label.json?search=id%3A%2249f6182a-5e0f-45ea-8a0f-b774ef28a98f%22

spl effective date

2025-12-22

spl set id

ae71c003-883a-4cd8-ad50-e8cc9a54e971

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

BLA761091

brand names

HERZUMA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 566
end exclusive: true
exact text: agonist indicated in adults for: the treatment of HER2-overexpressing breast cancer. ( 1.1 , 1.2 ) the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. ( 1.3 ) Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product. ( 1 , 2.2 ) 1.1 Adjuvant Breast Cancer HERZUMA is indicated in adults for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see C
label id: 49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start: 58

current approval status

not_reconciled

duplicate text group

dup-cd09d312759578093922

extraction review status

automated_candidate_pending_source_review

generic names

TRASTUZUMAB

ind-span-5b237592ee6fc45039b1

label id

49f6182a-5e0f-45ea-8a0f-b774ef28a98f

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 366
end exclusive: true
exact text: ( 1.3 ) Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.
label id: 49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start: 258

source url

https://api.fda.gov/drug/label.json?search=id%3A%2249f6182a-5e0f-45ea-8a0f-b774ef28a98f%22

spl effective date

2025-12-22

spl set id

ae71c003-883a-4cd8-ad50-e8cc9a54e971

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

BLA761091

brand names

HERZUMA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 578
end exclusive: true
exact text: ent of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. ( 1.3 ) Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product. ( 1 , 2.2 ) 1.1 Adjuvant Breast Cancer HERZUMA is indicated in adults for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Stud
label id: 49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start: 167

current approval status

not_reconciled

duplicate text group

dup-786213e2244204c419c2

extraction review status

automated_candidate_pending_source_review

generic names

TRASTUZUMAB

ind-span-0986f855506793015d9c

label id

49f6182a-5e0f-45ea-8a0f-b774ef28a98f

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 378
end exclusive: true
exact text: ( 1 , 2.2 )
label id: 49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start: 367

source url

https://api.fda.gov/drug/label.json?search=id%3A%2249f6182a-5e0f-45ea-8a0f-b774ef28a98f%22

spl effective date

2025-12-22

spl set id

ae71c003-883a-4cd8-ad50-e8cc9a54e971

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

BLA761091

brand names

HERZUMA

classification reasons

explicit_positive_indication_predicate
diagnostic_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1191
end exclusive: true
exact text: overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. ( 1.3 ) Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product. ( 1 , 2.2 ) 1.1 Adjuvant Breast Cancer HERZUMA is indicated in adults for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies (14.1) ] ) breast cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel as part of a treatment regimen with docetaxel and carboplatin as a single agent following multi-modality anthracycline based therapy Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2) ] . 1.2 Metastatic Breast Cancer HERZUMA is indicated in adults: In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer As a single agent for treatment of
label id: 49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start: 179

current approval status

not_reconciled

duplicate text group

dup-7c229afdd817b00f15c7

extraction review status

automated_candidate_pending_source_review

generic names

TRASTUZUMAB

ind-span-4409a411b0e58afd1010

label id

49f6182a-5e0f-45ea-8a0f-b774ef28a98f

positive predicate support span

end: 426
end exclusive: true
exact text: is indicated
label id: 49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start: 414

qualifier mentions

context exact
1.1 Adjuvant Breast Cancer HERZUMA is indicated in adults for adjuvant treatment of HER2 overexpressing node positive
kind
age
polarity
not_inferred
span
end
436
end exclusive
true
exact text
adults
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
430
context exact
er HERZUMA is indicated in adults for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Cl
kind
biomarker
polarity
not_inferred
span
end
507
end exclusive
true
exact text
HER2 overexpressing node positive or node ne
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
463
context exact
1.1 Adjuvant Breast Cancer HERZUMA is indicated in adults for adjuvant treatment of HER2 overexpressing nod
kind
stage_or_setting
polarity
not_inferred
span
end
426
end exclusive
true
exact text
Adjuvant Breast Cancer HERZUMA is indicated
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
383
context exact
1 Adjuvant Breast Cancer HERZUMA is indicated in adults for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one hi
kind
stage_or_setting
polarity
not_inferred
span
end
484
end exclusive
true
exact text
adjuvant treatment of HER2 overexpressing n
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
441
context exact
part of a treatment regimen with docetaxel and carboplatin as a single agent following multi-modality anthracycline based therapy Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2) ] .
kind
regimen
polarity
not_inferred
span
end
957
end exclusive
true
exact text
as a single agent following multi-modality anthracycline based therapy Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see D
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
780

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 991
end exclusive: true
exact text: 1.1 Adjuvant Breast Cancer HERZUMA is indicated in adults for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies (14.1) ] ) breast cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel as part of a treatment regimen with docetaxel and carboplatin as a single agent following multi-modality anthracycline based therapy Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2) ] .
label id: 49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start: 379

source url

https://api.fda.gov/drug/label.json?search=id%3A%2249f6182a-5e0f-45ea-8a0f-b774ef28a98f%22

spl effective date

2025-12-22

spl set id

ae71c003-883a-4cd8-ad50-e8cc9a54e971

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

diagnostic_candidate

Passage 6 · positive indication candidate

application numbers

BLA761091

brand names

HERZUMA

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: 1513
end exclusive: true
exact text: agent following multi-modality anthracycline based therapy Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2) ] . 1.2 Metastatic Breast Cancer HERZUMA is indicated in adults: In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2) ] . 1.3 Metastatic Gastric Cancer HERZUMA is indicated in adul
label id: 49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start: 792

current approval status

not_reconciled

duplicate text group

dup-d356ccaddeb2e50e74b0

extraction review status

automated_candidate_pending_source_review

generic names

TRASTUZUMAB

ind-span-65f494386261d60eb502

label id

49f6182a-5e0f-45ea-8a0f-b774ef28a98f

positive predicate support span

end: 1041
end exclusive: true
exact text: is indicated
label id: 49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start: 1029

qualifier mentions

context exact
1.2 Metastatic Breast Cancer HERZUMA is indicated in adults: In combination with paclitaxel for first-line treatment of
kind
age
polarity
not_inferred
span
end
1051
end exclusive
true
exact text
adults
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
1045
context exact
1.2 Metastatic Breast Cancer HERZUMA is indicated in adults: In combination with paclitaxel for first-line
kind
biomarker
polarity
not_inferred
span
end
1039
end exclusive
true
exact text
Metastatic Breast Cancer HERZUMA is indicat
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
996
context exact
In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer As a single agent for treatment of HER2-overexpressing brea
kind
biomarker
polarity
not_inferred
span
end
1156
end exclusive
true
exact text
HER2-overexpressing metastatic breast cancer
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
1112
context exact
metastatic breast cancer As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for me
kind
biomarker
polarity
not_inferred
span
end
1236
end exclusive
true
exact text
HER2-overexpressing breast cancer in patient
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
1192
context exact
nts who have received one or more chemotherapy regimens for metastatic disease.
kind
biomarker
polarity
not_inferred
span
end
1312
end exclusive
true
exact text
metastatic disease
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
1294
context exact
1.2 Metastatic Breast Cancer HERZUMA is indicated in adults: In combination with paclitaxel for first-line tr
kind
stage_or_setting
polarity
not_inferred
span
end
1041
end exclusive
true
exact text
Metastatic Breast Cancer HERZUMA is indicated
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
996
context exact
paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer As a single agent for treatment of HER2-overexpressing breast cancer in patients
kind
stage_or_setting
polarity
not_inferred
span
end
1177
end exclusive
true
exact text
metastatic breast cancer As a single agent fo
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
1132
context exact
nts who have received one or more chemotherapy regimens for metastatic disease.
kind
stage_or_setting
polarity
not_inferred
span
end
1312
end exclusive
true
exact text
metastatic disease
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
1294
context exact
is indicated in adults: In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.
kind
prior_therapy_or_line
polarity
not_inferred
span
end
1258
end exclusive
true
exact text
first-line treatment of HER2-overexpressing metastatic breast cancer As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received on
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
1088
context exact
.2 Metastatic Breast Cancer HERZUMA is indicated in adults: In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens fo
kind
regimen
polarity
not_inferred
span
end
1232
end exclusive
true
exact text
In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer As a single agent for treatment of HER2-overexpressing breast cancer in pat
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
1053

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 1313
end exclusive: true
exact text: 1.2 Metastatic Breast Cancer HERZUMA is indicated in adults: In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.
label id: 49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start: 992

source url

https://api.fda.gov/drug/label.json?search=id%3A%2249f6182a-5e0f-45ea-8a0f-b774ef28a98f%22

spl effective date

2025-12-22

spl set id

ae71c003-883a-4cd8-ad50-e8cc9a54e971

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 · unclassified context

application numbers

BLA761091

brand names

HERZUMA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1654
end exclusive: true
exact text: R2-overexpressing metastatic breast cancer As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2) ] . 1.3 Metastatic Gastric Cancer HERZUMA is indicated in adults, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastr
label id: 49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start: 1114

current approval status

not_reconciled

duplicate text group

dup-cef0a02277dbafc0c1b6

extraction review status

automated_candidate_pending_source_review

generic names

TRASTUZUMAB

ind-span-783f7d8d113efe904e86

label id

49f6182a-5e0f-45ea-8a0f-b774ef28a98f

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 1454
end exclusive: true
exact text: Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2) ] .
label id: 49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start: 1314

source url

https://api.fda.gov/drug/label.json?search=id%3A%2249f6182a-5e0f-45ea-8a0f-b774ef28a98f%22

spl effective date

2025-12-22

spl set id

ae71c003-883a-4cd8-ad50-e8cc9a54e971

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 8 · positive indication candidate

application numbers

BLA761091

brand names

HERZUMA

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: 1903
end exclusive: true
exact text: one or more chemotherapy regimens for metastatic disease. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2) ] . 1.3 Metastatic Gastric Cancer HERZUMA is indicated in adults, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2) ] .
label id: 49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start: 1255

current approval status

not_reconciled

duplicate text group

dup-b47497f8d6f5bbb32304

extraction review status

automated_candidate_pending_source_review

generic names

TRASTUZUMAB

ind-span-f78a5f7316ab1b571a95

label id

49f6182a-5e0f-45ea-8a0f-b774ef28a98f

positive predicate support span

end: 1505
end exclusive: true
exact text: is indicated
label id: 49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start: 1493

qualifier mentions

context exact
1.3 Metastatic Gastric Cancer HERZUMA is indicated in adults, in combination with cisplatin and capecitabine or 5-fluoro
kind
age
polarity
not_inferred
span
end
1515
end exclusive
true
exact text
adults
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
1509
context exact
1.3 Metastatic Gastric Cancer HERZUMA is indicated in adults, in combination with cisplatin and capecitabin
kind
biomarker
polarity
not_inferred
span
end
1502
end exclusive
true
exact text
Metastatic Gastric Cancer HERZUMA is indica
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
1459
context exact
abine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received
kind
biomarker
polarity
not_inferred
span
end
1662
end exclusive
true
exact text
HER2 overexpressing metastatic gastric or ga
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
1618
context exact
on adenocarcinoma who have not received prior treatment for metastatic disease.
kind
biomarker
polarity
not_inferred
span
end
1761
end exclusive
true
exact text
metastatic disease
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
1743
context exact
1.3 Metastatic Gastric Cancer HERZUMA is indicated in adults, in combination with cisplatin and capecitabine
kind
stage_or_setting
polarity
not_inferred
span
end
1504
end exclusive
true
exact text
Metastatic Gastric Cancer HERZUMA is indicate
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
1459
context exact
cil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for
kind
stage_or_setting
polarity
not_inferred
span
end
1683
end exclusive
true
exact text
metastatic gastric or gastroesophageal juncti
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
1638
context exact
on adenocarcinoma who have not received prior treatment for metastatic disease.
kind
stage_or_setting
polarity
not_inferred
span
end
1761
end exclusive
true
exact text
metastatic disease
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
1743
context exact
troesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.
kind
prior_therapy_or_line
polarity
not_inferred
span
end
1761
end exclusive
true
exact text
prior treatment for metastatic disease
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
1723
context exact
3 Metastatic Gastric Cancer HERZUMA is indicated in adults, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic di
kind
regimen
polarity
not_inferred
span
end
1696
end exclusive
true
exact text
in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarci
label id
49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start
1517

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 1762
end exclusive: true
exact text: 1.3 Metastatic Gastric Cancer HERZUMA is indicated in adults, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.
label id: 49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start: 1455

source url

https://api.fda.gov/drug/label.json?search=id%3A%2249f6182a-5e0f-45ea-8a0f-b774ef28a98f%22

spl effective date

2025-12-22

spl set id

ae71c003-883a-4cd8-ad50-e8cc9a54e971

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 9 · unclassified context

application numbers

BLA761091

brand names

HERZUMA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1903
end exclusive: true
exact text: or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2) ] .
label id: 49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start: 1563

current approval status

not_reconciled

duplicate text group

dup-cef0a02277dbafc0c1b6

extraction review status

automated_candidate_pending_source_review

generic names

TRASTUZUMAB

ind-span-a185d77c438699b412b3

label id

49f6182a-5e0f-45ea-8a0f-b774ef28a98f

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 1903
end exclusive: true
exact text: Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2) ] .
label id: 49f6182a-5e0f-45ea-8a0f-b774ef28a98f
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 870c3f1e87aa20ebac5469d6194aa96e7f4206650fa5e1b056f8860960c3a1c6
start: 1763

source url

https://api.fda.gov/drug/label.json?search=id%3A%2249f6182a-5e0f-45ea-8a0f-b774ef28a98f%22

spl effective date

2025-12-22

spl set id

ae71c003-883a-4cd8-ad50-e8cc9a54e971

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