LABELS · 4382adc1-c177-44e4-988f-3f89ffecb676

INLYTA

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: 2025-02-19
Captured: 2026-09-09T23:37:44.904352+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE INLYTA is a kinase inhibitor indicated: • in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) • in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC. ( 1.1 ) • as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. ( 1.2 ) 1.1 First-Line Advanced Renal Cell Carcinoma INLYTA in combination with avelumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC). INLYTA in combination with pembrolizumab is indicated for the first-line treatment of patients with advanced RCC. 1.2 Second-Line Advanced Renal Cell Carcinoma INLYTA as a single agent is indicated for the treatment of advanced RCC after failure of one prior systemic therapy.

Full extracted label fields

application numbers

NDA202324

boxed warning exact

brand names

INLYTA

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=84137882-e000-47da-bd5b-fa76ab3c76f9

generic names

AXITINIB

4382adc1-c177-44e4-988f-3f89ffecb676

indications and usage exact

1 INDICATIONS AND USAGE INLYTA is a kinase inhibitor indicated: • in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) • in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC. ( 1.1 ) • as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. ( 1.2 ) 1.1 First-Line Advanced Renal Cell Carcinoma INLYTA in combination with avelumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC). INLYTA in combination with pembrolizumab is indicated for the first-line treatment of patients with advanced RCC. 1.2 Second-Line Advanced Renal Cell Carcinoma INLYTA as a single agent is indicated for the treatment of advanced RCC after failure of one prior systemic therapy.

indications and usage tables exact

is original packager

true

manufacturer names

Pfizer Laboratories Div Pfizer Inc

matched search terms

carcinoma

package ndcs

0069-0145-01
0069-0151-11

product ndcs

0069-0145
0069-0151

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

1243004
1243010
1243012
1243014

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 · indication intro context

application numbers

NDA202324

brand names

INLYTA

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement
incomplete_colon_led_indication_intro

clinical review status

pending

content role

indication_intro_context

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end: 263
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exact text: 1 INDICATIONS AND USAGE INLYTA is a kinase inhibitor indicated: • in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) • in combination with pembrolizumab, for the first-line treatment of patient
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current approval status

not_reconciled

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generic names

AXITINIB

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label id

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exact text: is a kinase inhibitor indicated
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source text sha256: 4c34fbfc0fe24d596117c41aaa5cced7bd34ea395b0d183a0006f6201bf585c4
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qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

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source defined aliases

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exact text: 1 INDICATIONS AND USAGE INLYTA is a kinase inhibitor indicated:
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source text sha256: 4c34fbfc0fe24d596117c41aaa5cced7bd34ea395b0d183a0006f6201bf585c4
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%224382adc1-c177-44e4-988f-3f89ffecb676%22

spl effective date

2025-02-19

spl set id

84137882-e000-47da-bd5b-fa76ab3c76f9

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

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

use intent

not_applicable

Passage 2 · positive indication candidate

application numbers

NDA202324

brand names

INLYTA

classification reasons

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tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

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context span

end: 378
end exclusive: true
exact text: 1 INDICATIONS AND USAGE INLYTA is a kinase inhibitor indicated: • in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) • in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC. ( 1.1 ) • as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after fa
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source array index: 0
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source text sha256: 4c34fbfc0fe24d596117c41aaa5cced7bd34ea395b0d183a0006f6201bf585c4
start: 0

current approval status

not_reconciled

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generic names

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label id

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exact text: is a kinase inhibitor indicated
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qualifier mentions

context exact
ith avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
kind
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end
177
end exclusive
true
exact text
advanced renal cell carcinoma (RCC)
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context exact
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kind
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177
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exact text
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source text sha256
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context exact
• in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
kind
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exact text
in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC)
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regulatory links

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exact text: • in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
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start: 64

source url

https://api.fda.gov/drug/label.json?search=id%3A%224382adc1-c177-44e4-988f-3f89ffecb676%22

spl effective date

2025-02-19

spl set id

84137882-e000-47da-bd5b-fa76ab3c76f9

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

NDA202324

brand names

INLYTA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 386
end exclusive: true
exact text: 1 INDICATIONS AND USAGE INLYTA is a kinase inhibitor indicated: • in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) • in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC. ( 1.1 ) • as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of
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not_reconciled

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generic names

AXITINIB

ind-span-5ff923e0553880996091

label id

4382adc1-c177-44e4-988f-3f89ffecb676

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

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source batch sha256

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source defined aliases

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exact text: ( 1.1 )
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source url

https://api.fda.gov/drug/label.json?search=id%3A%224382adc1-c177-44e4-988f-3f89ffecb676%22

spl effective date

2025-02-19

spl set id

84137882-e000-47da-bd5b-fa76ab3c76f9

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

NDA202324

brand names

INLYTA

classification reasons

inherited_predicate_from_same_label_section_requires_review
no_tumor_directed_keyword_in_positive_statement

clinical review status

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content role

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context span

end: 483
end exclusive: true
exact text: 1 INDICATIONS AND USAGE INLYTA is a kinase inhibitor indicated: • in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) • in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC. ( 1.1 ) • as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. ( 1.2 ) 1.1 First-Line Advanced Renal Cell Carcinoma INLYTA in combi
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current approval status

not_reconciled

duplicate text group

dup-0ccfa52710f821f78625

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generic names

AXITINIB

ind-span-a1f54985dc2e7656c2b8

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exact text: is a kinase inhibitor indicated
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qualifier mentions

context exact
embrolizumab, for the first-line treatment of patients with advanced RCC.
kind
stage_or_setting
polarity
not_inferred
span
end
282
end exclusive
true
exact text
advanced RCC
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context exact
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exact text
first-line treatment of patients with advanced RCC
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context exact
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exact text
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regulatory links

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exact text: • in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC.
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source url

https://api.fda.gov/drug/label.json?search=id%3A%224382adc1-c177-44e4-988f-3f89ffecb676%22

spl effective date

2025-02-19

spl set id

84137882-e000-47da-bd5b-fa76ab3c76f9

spl version

structured fields status

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structured indication

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

use intent

non_oncology_or_unclear_candidate

Passage 5 · unclassified context

application numbers

NDA202324

brand names

INLYTA

classification reasons

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clinical review status

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end exclusive: true
exact text: h avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) • in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC. ( 1.1 ) • as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. ( 1.2 ) 1.1 First-Line Advanced Renal Cell Carcinoma INLYTA in combination w
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ind-span-13f587ef3b7829083bf2

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positive predicate support span

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qualifier mentions

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exact text: ( 1.1 )
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source url

https://api.fda.gov/drug/label.json?search=id%3A%224382adc1-c177-44e4-988f-3f89ffecb676%22

spl effective date

2025-02-19

spl set id

84137882-e000-47da-bd5b-fa76ab3c76f9

spl version

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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 6 · positive indication candidate

application numbers

NDA202324

brand names

INLYTA

classification reasons

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exact text: ab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) • in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC. ( 1.1 ) • as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. ( 1.2 ) 1.1 First-Line Advanced Renal Cell Carcinoma INLYTA in combination with avelumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC). INLYTA in comb
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qualifier mentions

context exact
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advanced renal cell carcinoma (RCC) after f
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regulatory links

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exact text: • as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy.
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offset unit: unicode_code_points
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source text sha256: 4c34fbfc0fe24d596117c41aaa5cced7bd34ea395b0d183a0006f6201bf585c4
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source url

https://api.fda.gov/drug/label.json?search=id%3A%224382adc1-c177-44e4-988f-3f89ffecb676%22

spl effective date

2025-02-19

spl set id

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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

NDA202324

brand names

INLYTA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

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Preserved source evidence · Not medical advice