LABELS · 1cd448bd-5230-450c-ad4c-359e6d54cd2b

ERBITUX

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: 2026-04-16
Captured: 2026-09-09T23:37:39.774134+00:00
Current indication reconciliation: Not reconciled

Boxed warning in this label

WARNING: INFUSION REACTIONS and CARDIOPULMONARY ARREST Infusion Reactions: ERBITUX can cause serious and fatal infusion reactions [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6 )] . Immediately interrupt and permanently discontinue ERBITUX for serious infusion reactions [see Dosage and Administration ( 2.5 )] . Cardiopulmonary Arrest: Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving ERBITUX with radiation therapy or a cetuximab product with platinum-based therapy and fluorouracil. Monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after ERBITUX administration [see Warnings and Precautions ( 5.2 , 5.6 )] . WARNING: INFUSION REACTIONS and CARDIOPULMONARY ARREST See full prescribing information for complete boxed warning. ERBITUX can cause serious and fatal infusion reactions. ( 5.1 , 6 ) Immediately interrupt and permanently discontinue ERBITUX for serious infusion reactions. ( 2.5 ) Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving ERBITUX with radiation therapy or with a cetuximab product with platinum-based therapy and fluorouracil. Monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after ERBITUX administration. ( 5.2 , 5.6 )

Indications and usage: exact source text

1 INDICATIONS AND USAGE ERBITUX ® is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of: Head and Neck Cancer Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. ( 1.1 , 14.1 ) Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil. ( 1.1 , 14.1 ) Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy. ( 1.1 , 14.1 ) Colorectal Cancer K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with FOLFIRI for first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan. ( 1.2 , 5.7 , 12.1 , 14.2 ) Limitations of Use: ERBITUX is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown. ( 5.7 ) BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. ( 1.3 ) 1.1 Squamous Cell Carcinoma of the Head and Neck (SCCHN) ERBITUX ® is indicated: in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN). in combination with platinum-based therapy with fluorouracil for the first-line treatment of patients with recurrent locoregional disease or metastatic SCCHN. as a single-agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed. 1.2 K-Ras Wild-type, EGFR-expressing Colorectal Cancer (CRC) ERBITUX is indicated for the treatment of K-Ras wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by an FDA-approved test [see Dosage and Administration ( 2.2 )] : in combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan. Limitations of Use: ERBITUX is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown [see Warnings and Precautions ( 5.7 )] . 1.3 BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) ERBITUX is indicated, in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy [see Dosage and Administration ( 2.3 )] .

Full extracted label fields

application numbers

BLA125084

boxed warning exact

WARNING: INFUSION REACTIONS and CARDIOPULMONARY ARREST Infusion Reactions: ERBITUX can cause serious and fatal infusion reactions [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6 )] . Immediately interrupt and permanently discontinue ERBITUX for serious infusion reactions [see Dosage and Administration ( 2.5 )] . Cardiopulmonary Arrest: Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving ERBITUX with radiation therapy or a cetuximab product with platinum-based therapy and fluorouracil. Monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after ERBITUX administration [see Warnings and Precautions ( 5.2 , 5.6 )] . WARNING: INFUSION REACTIONS and CARDIOPULMONARY ARREST See full prescribing information for complete boxed warning. ERBITUX can cause serious and fatal infusion reactions. ( 5.1 , 6 ) Immediately interrupt and permanently discontinue ERBITUX for serious infusion reactions. ( 2.5 ) Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving ERBITUX with radiation therapy or with a cetuximab product with platinum-based therapy and fluorouracil. Monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after ERBITUX administration. ( 5.2 , 5.6 )

brand names

ERBITUX

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8bc6397e-4bd8-4d37-a007-a327e4da34d9

generic names

CETUXIMAB

1cd448bd-5230-450c-ad4c-359e6d54cd2b

indications and usage exact

1 INDICATIONS AND USAGE ERBITUX ® is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of: Head and Neck Cancer Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. ( 1.1 , 14.1 ) Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil. ( 1.1 , 14.1 ) Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy. ( 1.1 , 14.1 ) Colorectal Cancer K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with FOLFIRI for first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan. ( 1.2 , 5.7 , 12.1 , 14.2 ) Limitations of Use: ERBITUX is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown. ( 5.7 ) BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. ( 1.3 ) 1.1 Squamous Cell Carcinoma of the Head and Neck (SCCHN) ERBITUX ® is indicated: in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN). in combination with platinum-based therapy with fluorouracil for the first-line treatment of patients with recurrent locoregional disease or metastatic SCCHN. as a single-agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed. 1.2 K-Ras Wild-type, EGFR-expressing Colorectal Cancer (CRC) ERBITUX is indicated for the treatment of K-Ras wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by an FDA-approved test [see Dosage and Administration ( 2.2 )] : in combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan. Limitations of Use: ERBITUX is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown [see Warnings and Precautions ( 5.7 )] . 1.3 BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) ERBITUX is indicated, in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy [see Dosage and Administration ( 2.3 )] .

indications and usage tables exact

is original packager

true

manufacturer names

ImClone LLC

matched search terms

cancer
carcinoma

package ndcs

66733-948-23
66733-958-23

product ndcs

66733-948
66733-958

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Indications and Usage ( 1.3 ) 09/2021 Dosage and Administration Recommended Dosage for Squamous Cell Carcinoma of the Head and Neck (SCCHN) ( 2.1 ) 04/2021 Recommended Dosage for Colorectal Cancer (CRC) ( 2.2 ) 04/2021 Dosage and Administration ( 2.1 , 2.3 ) 09/2021 Warnings and Precautions, Infusion Reactions ( 5.1 ) 11/2020

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS

rxcuis

1657658
1657660
1657663
1657664

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00000.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

BLA125084

brand names

ERBITUX

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: 454
end exclusive: true
exact text: 1 INDICATIONS AND USAGE ERBITUX ® is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of: Head and Neck Cancer Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. ( 1.1 , 14.1 ) Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil. ( 1.1 , 14.1 ) Recurrent or meta
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 0

current approval status

not_reconciled

duplicate text group

dup-3f4cd124bacb10c95587

extraction review status

automated_candidate_pending_source_review

generic names

CETUXIMAB

ind-span-315c0900bc2274c3f489

label id

1cd448bd-5230-450c-ad4c-359e6d54cd2b

positive predicate support span

end: 100
end exclusive: true
exact text: is an epidermal growth factor receptor (EGFR) antagonist indicated
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 34

qualifier mentions

context exact
AND USAGE ERBITUX ® is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of: Head and Neck Cancer Locally or regionally advanced squamou
kind
biomarker
polarity
not_inferred
span
end
118
end exclusive
true
exact text
EGFR) antagonist indicated for treatment of:
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
74
context exact
or treatment of: Head and Neck Cancer Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy.
kind
stage_or_setting
polarity
not_inferred
span
end
205
end exclusive
true
exact text
advanced squamous cell carcinoma of the hea
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
162
context exact
nally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy.
kind
regimen
polarity
not_inferred
span
end
253
end exclusive
true
exact text
in combination with radiation therapy
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
216

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

abbreviation
CRC
definition exact
Colorectal Cancer
definition span
end
1211
end exclusive
true
exact text
Colorectal Cancer (CRC)
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1188

source span

end: 254
end exclusive: true
exact text: 1 INDICATIONS AND USAGE ERBITUX ® is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of: Head and Neck Cancer Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy.
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%221cd448bd-5230-450c-ad4c-359e6d54cd2b%22

spl effective date

2026-04-16

spl set id

8bc6397e-4bd8-4d37-a007-a327e4da34d9

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

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

use intent

tumor_directed_candidate

Passage 2 · positive indication candidate

application numbers

BLA125084

brand names

ERBITUX

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: 621
end exclusive: true
exact text: h factor receptor (EGFR) antagonist indicated for treatment of: Head and Neck Cancer Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. ( 1.1 , 14.1 ) Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil. ( 1.1 , 14.1 ) Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy. ( 1.1 , 14.1 ) Colorectal Cancer K-Ras wild-type, EGFR-expressing, metast
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 55

current approval status

not_reconciled

duplicate text group

dup-156bdee3a99f06dbeb5d

extraction review status

automated_candidate_pending_source_review

generic names

CETUXIMAB

ind-span-46f11cae251039604aa1

label id

1cd448bd-5230-450c-ad4c-359e6d54cd2b

positive predicate support span

end: 100
end exclusive: true
exact text: is an epidermal growth factor receptor (EGFR) antagonist indicated
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 34

qualifier mentions

context exact
( 1.1 , 14.1 ) Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with
kind
biomarker
polarity
not_inferred
span
end
347
end exclusive
true
exact text
metastatic squamous cell carcinoma of the h
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
304
context exact
( 1.1 , 14.1 ) Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination
kind
stage_or_setting
polarity
not_inferred
span
end
314
end exclusive
true
exact text
Recurrent locoregional disease or metastatic
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
270
context exact
or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil.
kind
regimen
polarity
not_inferred
span
end
420
end exclusive
true
exact text
in combination with platinum-based therapy with fluorouracil
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
360

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

abbreviation
CRC
definition exact
Colorectal Cancer
definition span
end
1211
end exclusive
true
exact text
Colorectal Cancer (CRC)
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1188

source span

end: 421
end exclusive: true
exact text: ( 1.1 , 14.1 ) Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil.
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 255

source url

https://api.fda.gov/drug/label.json?search=id%3A%221cd448bd-5230-450c-ad4c-359e6d54cd2b%22

spl effective date

2026-04-16

spl set id

8bc6397e-4bd8-4d37-a007-a327e4da34d9

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

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

use intent

tumor_directed_candidate

Passage 3 · unclassified context

application numbers

BLA125084

brand names

ERBITUX

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 747
end exclusive: true
exact text: bination with radiation therapy. ( 1.1 , 14.1 ) Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil. ( 1.1 , 14.1 ) Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy. ( 1.1 , 14.1 ) Colorectal Cancer K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with FOLFIRI for first-line treatment, in combinat
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 222

current approval status

not_reconciled

duplicate text group

dup-bb061960faabac880bb4

extraction review status

automated_candidate_pending_source_review

generic names

CETUXIMAB

ind-span-cdd1d75d43c710b520d9

label id

1cd448bd-5230-450c-ad4c-359e6d54cd2b

positive predicate support span

Source null

qualifier mentions

context exact
( 1.1 , 14.1 ) Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy.
kind
biomarker
polarity
not_inferred
span
end
493
end exclusive
true
exact text
metastatic squamous cell carcinoma of the h
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
450
context exact
( 1.1 , 14.1 ) Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based th
kind
stage_or_setting
polarity
not_inferred
span
end
481
end exclusive
true
exact text
Recurrent or metastatic squamous cell carcin
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
437

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

abbreviation
CRC
definition exact
Colorectal Cancer
definition span
end
1211
end exclusive
true
exact text
Colorectal Cancer (CRC)
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1188

source span

end: 547
end exclusive: true
exact text: ( 1.1 , 14.1 ) Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy.
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 422

source url

https://api.fda.gov/drug/label.json?search=id%3A%221cd448bd-5230-450c-ad4c-359e6d54cd2b%22

spl effective date

2026-04-16

spl set id

8bc6397e-4bd8-4d37-a007-a327e4da34d9

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

BLA125084

brand names

ERBITUX

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: 1161
end exclusive: true
exact text: ad and neck in combination with platinum-based therapy with fluorouracil. ( 1.1 , 14.1 ) Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy. ( 1.1 , 14.1 ) Colorectal Cancer K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with FOLFIRI for first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan. ( 1.2 , 5.7 , 12.1 , 14.2 ) Limitations of Use: ERBITUX is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown. ( 5.7 ) BRAF V600E Mu
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 348

current approval status

not_reconciled

duplicate text group

dup-2ea547e9e7dfd769d484

extraction review status

automated_candidate_pending_source_review

generic names

CETUXIMAB

ind-span-e8023ae6c80d54a40fec

label id

1cd448bd-5230-450c-ad4c-359e6d54cd2b

positive predicate support span

end: 100
end exclusive: true
exact text: is an epidermal growth factor receptor (EGFR) antagonist indicated
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 34

qualifier mentions

context exact
( 1.1 , 14.1 ) Colorectal Cancer K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-appro
kind
biomarker
polarity
not_inferred
span
end
613
end exclusive
true
exact text
EGFR-expressing
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
598
context exact
14.1 ) Colorectal Cancer K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with FOLFIRI for firs
kind
biomarker
polarity
not_inferred
span
end
658
end exclusive
true
exact text
metastatic colorectal cancer as determined
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
615
context exact
14.1 ) Colorectal Cancer K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with FOLFIRI for first-
kind
stage_or_setting
polarity
not_inferred
span
end
660
end exclusive
true
exact text
metastatic colorectal cancer as determined by
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
615
context exact
eatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxaliplatin-
kind
stage_or_setting
polarity
not_inferred
span
end
830
end exclusive
true
exact text
refractory to irinotecan-based chemotherapy
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
787
context exact
ned by an FDA-approved test in combination with FOLFIRI for first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolera
kind
prior_therapy_or_line
polarity
not_inferred
span
end
884
end exclusive
true
exact text
first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxalip
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
714
context exact
tic colorectal cancer as determined by an FDA-approved test in combination with FOLFIRI for first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemother
kind
regimen
polarity
not_inferred
span
end
861
end exclusive
true
exact text
in combination with FOLFIRI for first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
682

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

abbreviation
CRC
definition exact
Colorectal Cancer
definition span
end
1211
end exclusive
true
exact text
Colorectal Cancer (CRC)
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1188

source span

end: 961
end exclusive: true
exact text: ( 1.1 , 14.1 ) Colorectal Cancer K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with FOLFIRI for first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 548

source url

https://api.fda.gov/drug/label.json?search=id%3A%221cd448bd-5230-450c-ad4c-359e6d54cd2b%22

spl effective date

2026-04-16

spl set id

8bc6397e-4bd8-4d37-a007-a327e4da34d9

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 5 · limitation of use

application numbers

BLA125084

brand names

ERBITUX

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 1339
end exclusive: true
exact text: ecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan. ( 1.2 , 5.7 , 12.1 , 14.2 ) Limitations of Use: ERBITUX is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown. ( 5.7 ) BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 762

current approval status

not_reconciled

duplicate text group

dup-4c078813b9d2fac91d65

extraction review status

automated_candidate_pending_source_review

generic names

CETUXIMAB

ind-span-46c03272cc8ec9c05555

label id

1cd448bd-5230-450c-ad4c-359e6d54cd2b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

abbreviation
CRC
definition exact
Colorectal Cancer
definition span
end
1211
end exclusive
true
exact text
Colorectal Cancer (CRC)
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1188

source span

end: 1139
end exclusive: true
exact text: ( 1.2 , 5.7 , 12.1 , 14.2 ) Limitations of Use: ERBITUX is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown.
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 962

source url

https://api.fda.gov/drug/label.json?search=id%3A%221cd448bd-5230-450c-ad4c-359e6d54cd2b%22

spl effective date

2026-04-16

spl set id

8bc6397e-4bd8-4d37-a007-a327e4da34d9

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 6 · unclassified context

application numbers

BLA125084

brand names

ERBITUX

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1606
end exclusive: true
exact text: lerant to irinotecan. ( 1.2 , 5.7 , 12.1 , 14.2 ) Limitations of Use: ERBITUX is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown. ( 5.7 ) BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. ( 1.3 ) 1.1 Squamous Cell Carcinoma of the Head and Neck (SCCHN) ERBITUX ® is indicated: in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cel
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 940

current approval status

not_reconciled

duplicate text group

dup-05594246539a1ebafd2e

extraction review status

automated_candidate_pending_source_review

generic names

CETUXIMAB

ind-span-c460877fe4b84942c2b8

label id

1cd448bd-5230-450c-ad4c-359e6d54cd2b

positive predicate support span

Source null

qualifier mentions

context exact
(CRC) in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E m
kind
age
polarity
not_inferred
span
end
1280
end exclusive
true
exact text
adult patients
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1266
context exact
( 5.7 ) BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) in combination with encorafenib, for the
kind
biomarker
polarity
not_inferred
span
end
1192
end exclusive
true
exact text
BRAF V600E Mutation-Positive Metastatic Colo
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1148
context exact
with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, aft
kind
biomarker
polarity
not_inferred
span
end
1329
end exclusive
true
exact text
metastatic colorectal cancer (CRC) with a B
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1286
context exact
( 5.7 ) BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) in combination with encorafenib, for the treatment of adult patients w
kind
stage_or_setting
polarity
not_inferred
span
end
1222
end exclusive
true
exact text
Metastatic Colorectal Cancer (CRC) in combina
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1177
context exact
with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after
kind
stage_or_setting
polarity
not_inferred
span
end
1331
end exclusive
true
exact text
metastatic colorectal cancer (CRC) with a BRA
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1286
context exact
V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.
kind
regimen
polarity
not_inferred
span
end
1391
end exclusive
true
exact text
in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1212

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

abbreviation
CRC
definition exact
Colorectal Cancer
definition span
end
1211
end exclusive
true
exact text
Colorectal Cancer (CRC)
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1188

source span

end: 1406
end exclusive: true
exact text: ( 5.7 ) BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 1140

source url

https://api.fda.gov/drug/label.json?search=id%3A%221cd448bd-5230-450c-ad4c-359e6d54cd2b%22

spl effective date

2026-04-16

spl set id

8bc6397e-4bd8-4d37-a007-a327e4da34d9

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

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

use intent

unclear

Passage 7 · unclassified context

application numbers

BLA125084

brand names

ERBITUX

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1614
end exclusive: true
exact text: CRC) in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. ( 1.3 ) 1.1 Squamous Cell Carcinoma of the Head and Neck (SCCHN) ERBITUX ® is indicated: in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcin
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 1207

current approval status

not_reconciled

duplicate text group

dup-14b25e74a6163b0789bc

extraction review status

automated_candidate_pending_source_review

generic names

CETUXIMAB

ind-span-738d846bb27bb1f2fc31

label id

1cd448bd-5230-450c-ad4c-359e6d54cd2b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

abbreviation
CRC
definition exact
Colorectal Cancer
definition span
end
1211
end exclusive
true
exact text
Colorectal Cancer (CRC)
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1188

source span

end: 1414
end exclusive: true
exact text: ( 1.3 )
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 1407

source url

https://api.fda.gov/drug/label.json?search=id%3A%221cd448bd-5230-450c-ad4c-359e6d54cd2b%22

spl effective date

2026-04-16

spl set id

8bc6397e-4bd8-4d37-a007-a327e4da34d9

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

BLA125084

brand names

ERBITUX

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: 2139
end exclusive: true
exact text: combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. ( 1.3 ) 1.1 Squamous Cell Carcinoma of the Head and Neck (SCCHN) ERBITUX ® is indicated: in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN). in combination with platinum-based therapy with fluorouracil for the first-line treatment of patients with recurrent locoregional disease or metastatic SCCHN. as a single-agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed. 1.2 K-Ras Wild-type, EGFR-expressing Colorectal Cancer (CRC) ERBITUX is indicated for the treatment of K-Ras wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cance
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 1215

current approval status

not_reconciled

duplicate text group

dup-b7ffa34abc23b86ed2be

extraction review status

automated_candidate_pending_source_review

generic names

CETUXIMAB

ind-span-865abbbf05855c4e9b4d

label id

1cd448bd-5230-450c-ad4c-359e6d54cd2b

positive predicate support span

end: 1494
end exclusive: true
exact text: is indicated
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 1482

qualifier mentions

context exact
reatment of patients with recurrent locoregional disease or metastatic SCCHN. as a single-agent for the treatment of patients with recur
kind
biomarker
polarity
not_inferred
span
end
1805
end exclusive
true
exact text
metastatic SCCHN
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1789
context exact
ingle-agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed.
kind
biomarker
polarity
not_inferred
span
end
1916
end exclusive
true
exact text
metastatic SCCHN for whom prior platinum-ba
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1873
context exact
therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN). in combination with platinum-based thera
kind
stage_or_setting
polarity
not_inferred
span
end
1628
end exclusive
true
exact text
advanced squamous cell carcinoma of the hea
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1585
context exact
fluorouracil for the first-line treatment of patients with recurrent locoregional disease or metastatic SCCHN. as a single-agent for the treatment of patients with
kind
stage_or_setting
polarity
not_inferred
span
end
1799
end exclusive
true
exact text
recurrent locoregional disease or metastatic
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1755
context exact
SCCHN. as a single-agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed.
kind
stage_or_setting
polarity
not_inferred
span
end
1904
end exclusive
true
exact text
recurrent or metastatic SCCHN for whom prior
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1860
context exact
ation with platinum-based therapy with fluorouracil for the first-line treatment of patients with recurrent locoregional disease or metastatic SCCHN. as a single-agent for the treatment of patients with recur
kind
prior_therapy_or_line
polarity
not_inferred
span
end
1805
end exclusive
true
exact text
first-line treatment of patients with recurrent locoregional disease or metastatic SCCHN
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1717
context exact
cinoma of the Head and Neck (SCCHN) ERBITUX ® is indicated: in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN). in combination with platinum-based therapy with fluorourac
kind
regimen
polarity
not_inferred
span
end
1646
end exclusive
true
exact text
in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN)
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1496
context exact
anced squamous cell carcinoma of the head and neck (SCCHN). in combination with platinum-based therapy with fluorouracil for the first-line treatment of patients with recurrent locoregional disease or metastatic SCCHN. as a single-agent for the treatment of patients with recur
kind
regimen
polarity
not_inferred
span
end
1805
end exclusive
true
exact text
in combination with platinum-based therapy with fluorouracil for the first-line treatment of patients with recurrent locoregional disease or metastatic SCCHN
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1648
context exact
ts with recurrent locoregional disease or metastatic SCCHN. as a single-agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed.
kind
regimen
polarity
not_inferred
span
end
1938
end exclusive
true
exact text
as a single-agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1807

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

abbreviation
CRC
definition exact
Colorectal Cancer
definition span
end
1211
end exclusive
true
exact text
Colorectal Cancer (CRC)
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1188

source span

end: 1939
end exclusive: true
exact text: 1.1 Squamous Cell Carcinoma of the Head and Neck (SCCHN) ERBITUX ® is indicated: in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN). in combination with platinum-based therapy with fluorouracil for the first-line treatment of patients with recurrent locoregional disease or metastatic SCCHN. as a single-agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed.
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 1415

source url

https://api.fda.gov/drug/label.json?search=id%3A%221cd448bd-5230-450c-ad4c-359e6d54cd2b%22

spl effective date

2026-04-16

spl set id

8bc6397e-4bd8-4d37-a007-a327e4da34d9

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 · positive indication candidate

application numbers

BLA125084

brand names

ERBITUX

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: 2746
end exclusive: true
exact text: patients with recurrent locoregional disease or metastatic SCCHN. as a single-agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed. 1.2 K-Ras Wild-type, EGFR-expressing Colorectal Cancer (CRC) ERBITUX is indicated for the treatment of K-Ras wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by an FDA-approved test [see Dosage and Administration ( 2.2 )] : in combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan. Limitations of Use: ERBITUX is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown [see Warnings and Precautions ( 5.7 )] . 1.3 BRAF
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 1740

current approval status

not_reconciled

duplicate text group

dup-eba02f9dbd9cb667149c

extraction review status

automated_candidate_pending_source_review

generic names

CETUXIMAB

ind-span-bd43fa2bd4f7341b1dc9

label id

1cd448bd-5230-450c-ad4c-359e6d54cd2b

positive predicate support span

end: 2021
end exclusive: true
exact text: is indicated
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 2009

qualifier mentions

context exact
1.2 K-Ras Wild-type, EGFR-expressing Colorectal Cancer (CRC) ERBITUX is indicated for the treatment of K-Ras wild-type, epide
kind
biomarker
polarity
not_inferred
span
end
2005
end exclusive
true
exact text
EGFR-expressing Colorectal Cancer (CRC) ERBI
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1961
context exact
tment of K-Ras wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by an FD
kind
biomarker
polarity
not_inferred
span
end
2110
end exclusive
true
exact text
EGFR)-expressing
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
2094
context exact
d-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by an FDA-approved test [see Dosage and Administratio
kind
biomarker
polarity
not_inferred
span
end
2155
end exclusive
true
exact text
metastatic colorectal cancer (mCRC) as dete
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
2112
context exact
d-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by an FDA-approved test [see Dosage and Administration
kind
stage_or_setting
polarity
not_inferred
span
end
2157
end exclusive
true
exact text
metastatic colorectal cancer (mCRC) as determ
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
2112
context exact
eatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxaliplatin-
kind
stage_or_setting
polarity
not_inferred
span
end
2415
end exclusive
true
exact text
refractory to irinotecan-based chemotherapy
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
2372
context exact
ion with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolera
kind
prior_therapy_or_line
polarity
not_inferred
span
end
2469
end exclusive
true
exact text
first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxalip
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
2299
context exact
FDA-approved test [see Dosage and Administration ( 2.2 )] : in combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxal
kind
regimen
polarity
not_inferred
span
end
2407
end exclusive
true
exact text
in combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chem
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
2228
context exact
tients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.
kind
regimen
polarity
not_inferred
span
end
2545
end exclusive
true
exact text
as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
2417

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

abbreviation
CRC
definition exact
Colorectal Cancer
definition span
end
1211
end exclusive
true
exact text
Colorectal Cancer (CRC)
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1188

source span

end: 2546
end exclusive: true
exact text: 1.2 K-Ras Wild-type, EGFR-expressing Colorectal Cancer (CRC) ERBITUX is indicated for the treatment of K-Ras wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by an FDA-approved test [see Dosage and Administration ( 2.2 )] : in combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 1940

source url

https://api.fda.gov/drug/label.json?search=id%3A%221cd448bd-5230-450c-ad4c-359e6d54cd2b%22

spl effective date

2026-04-16

spl set id

8bc6397e-4bd8-4d37-a007-a327e4da34d9

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 10 · limitation of use

application numbers

BLA125084

brand names

ERBITUX

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 2936
end exclusive: true
exact text: ecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan. Limitations of Use: ERBITUX is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown [see Warnings and Precautions ( 5.7 )] . 1.3 BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) ERBITUX is indicated, in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC)
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 2347

current approval status

not_reconciled

duplicate text group

dup-1638091753e0cff9e8d6

extraction review status

automated_candidate_pending_source_review

generic names

CETUXIMAB

ind-span-7a9749d0780659befdb4

label id

1cd448bd-5230-450c-ad4c-359e6d54cd2b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

abbreviation
CRC
definition exact
Colorectal Cancer
definition span
end
1211
end exclusive
true
exact text
Colorectal Cancer (CRC)
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1188

source span

end: 2736
end exclusive: true
exact text: Limitations of Use: ERBITUX is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown [see Warnings and Precautions ( 5.7 )] .
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 2547

source url

https://api.fda.gov/drug/label.json?search=id%3A%221cd448bd-5230-450c-ad4c-359e6d54cd2b%22

spl effective date

2026-04-16

spl set id

8bc6397e-4bd8-4d37-a007-a327e4da34d9

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 11 · positive indication candidate

application numbers

BLA125084

brand names

ERBITUX

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: 3062
end exclusive: true
exact text: inotecan. Limitations of Use: ERBITUX is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown [see Warnings and Precautions ( 5.7 )] . 1.3 BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) ERBITUX is indicated, in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy [see Dosage and Administration ( 2.3 )] .
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 2537

current approval status

not_reconciled

duplicate text group

dup-0d3248cc00d63fa347d8

extraction review status

automated_candidate_pending_source_review

generic names

CETUXIMAB

ind-span-be7b94c4e94e8c7bf389

label id

1cd448bd-5230-450c-ad4c-359e6d54cd2b

positive predicate support span

end: 2825
end exclusive: true
exact text: is indicated
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 2813

qualifier mentions

context exact
ated, in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E m
kind
age
polarity
not_inferred
span
end
2895
end exclusive
true
exact text
adult patients
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
2881
context exact
1.3 BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) ERBITUX is indicated, in combination wit
kind
biomarker
polarity
not_inferred
span
end
2785
end exclusive
true
exact text
BRAF V600E Mutation-Positive Metastatic Colo
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
2741
context exact
with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, aft
kind
biomarker
polarity
not_inferred
span
end
2944
end exclusive
true
exact text
metastatic colorectal cancer (CRC) with a B
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
2901
context exact
1.3 BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) ERBITUX is indicated, in combination with encorafenib, for the treatme
kind
stage_or_setting
polarity
not_inferred
span
end
2815
end exclusive
true
exact text
Metastatic Colorectal Cancer (CRC) ERBITUX is
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
2770
context exact
with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after
kind
stage_or_setting
polarity
not_inferred
span
end
2946
end exclusive
true
exact text
metastatic colorectal cancer (CRC) with a BRA
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
2901
context exact
ve Metastatic Colorectal Cancer (CRC) ERBITUX is indicated, in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy [see Dosage and Administration ( 2.3 )] .
kind
regimen
polarity
not_inferred
span
end
3006
end exclusive
true
exact text
in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
2827

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

abbreviation
CRC
definition exact
Colorectal Cancer
definition span
end
1211
end exclusive
true
exact text
Colorectal Cancer (CRC)
label id
1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start
1188

source span

end: 3062
end exclusive: true
exact text: 1.3 BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) ERBITUX is indicated, in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy [see Dosage and Administration ( 2.3 )] .
label id: 1cd448bd-5230-450c-ad4c-359e6d54cd2b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2aa38b051c0b74c4588675dd8468364207454886f5ec52091ee831e6c4250fb3
start: 2737

source url

https://api.fda.gov/drug/label.json?search=id%3A%221cd448bd-5230-450c-ad4c-359e6d54cd2b%22

spl effective date

2026-04-16

spl set id

8bc6397e-4bd8-4d37-a007-a327e4da34d9

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

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

use intent

tumor_directed_candidate

Preserved source evidence · Not medical advice