LABELS · 530eef58-b5ab-49f1-8d73-a2dae0356f24

SUTENT

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: 2026-02-20
Captured: 2026-09-09T23:37:47.659725+00:00
Current indication reconciliation: Not reconciled

Boxed warning in this label

WARNING: HEPATOTOXICITY Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue SUTENT as recommended [see Warnings and Precautions (5.1) ] . WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepatotoxicity may be severe, and in some cases fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue SUTENT as recommended [see Warnings and Precautions (5.1) ].

Indications and usage: exact source text

1 INDICATIONS AND USAGE SUTENT is a kinase inhibitor indicated for: • treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. ( 1.1 ) • treatment of adult patients with advanced renal cell carcinoma (RCC). ( 1.2 ) • adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. ( 1.3 ) • treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. ( 1.4 ) 1.1 Gastrointestinal Stromal Tumor SUTENT is indicated for the treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. 1.2 Advanced Renal Cell Carcinoma SUTENT is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC). 1.3 Adjuvant Treatment of Renal Cell Carcinoma SUTENT is indicated for the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. 1.4 Advanced Pancreatic Neuroendocrine Tumors SUTENT is indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease.

Full extracted label fields

application numbers

NDA021938

boxed warning exact

WARNING: HEPATOTOXICITY Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue SUTENT as recommended [see Warnings and Precautions (5.1) ] . WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepatotoxicity may be severe, and in some cases fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue SUTENT as recommended [see Warnings and Precautions (5.1) ].

brand names

SUTENT

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c

generic names

SUNITINIB MALATE

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indications and usage exact

1 INDICATIONS AND USAGE SUTENT is a kinase inhibitor indicated for: • treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. ( 1.1 ) • treatment of adult patients with advanced renal cell carcinoma (RCC). ( 1.2 ) • adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. ( 1.3 ) • treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. ( 1.4 ) 1.1 Gastrointestinal Stromal Tumor SUTENT is indicated for the treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. 1.2 Advanced Renal Cell Carcinoma SUTENT is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC). 1.3 Adjuvant Treatment of Renal Cell Carcinoma SUTENT is indicated for the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. 1.4 Advanced Pancreatic Neuroendocrine Tumors SUTENT is indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease.

indications and usage tables exact

is original packager

true

manufacturer names

Pfizer Laboratories Div Pfizer Inc

matched search terms

carcinoma
tumor
tumors

package ndcs

0069-0550-38
0069-0770-38
0069-0980-38
0069-0830-38

product ndcs

0069-0550
0069-0770
0069-0980
0069-0830

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

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rxcuis

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616292
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source batch

file

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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

NDA021938

brand names

SUTENT

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exact text: 1 INDICATIONS AND USAGE SUTENT is a kinase inhibitor indicated for: • treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. ( 1.1 ) • treatment of adult patients with advanced renal ce
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Passage 2 · positive indication candidate

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exact text: 1 INDICATIONS AND USAGE SUTENT is a kinase inhibitor indicated for: • treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. ( 1.1 ) • treatment of adult patients with advanced renal cell carcinoma (RCC). ( 1.2 ) • adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. ( 1.3 ) • treatment
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Passage 3 · unclassified context

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exact text: ATIONS AND USAGE SUTENT is a kinase inhibitor indicated for: • treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. ( 1.1 ) • treatment of adult patients with advanced renal cell carcinoma (RCC). ( 1.2 ) • adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. ( 1.3 ) • treatment of prog
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use intent

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Passage 4 · positive indication candidate

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exact text: ND USAGE SUTENT is a kinase inhibitor indicated for: • treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. ( 1.1 ) • treatment of adult patients with advanced renal cell carcinoma (RCC). ( 1.2 ) • adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. ( 1.3 ) • treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in
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fda indication exact
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Read indication-specific status → · whole_fda_indication_text_present

Passage 5 · unclassified context

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exact text: t patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. ( 1.1 ) • treatment of adult patients with advanced renal cell carcinoma (RCC). ( 1.2 ) • adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. ( 1.3 ) • treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult pa
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exact text: 1.3 Adjuvant Treatment of Renal Cell Carcinoma SUTENT is indicated for the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy.
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source url

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spl effective date

2026-02-20

spl set id

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spl version

structured fields status

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line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

tumor_directed_candidate

Passage 13 · positive indication candidate

application numbers

NDA021938

brand names

SUTENT

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

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exact text: vanced renal cell carcinoma (RCC). 1.3 Adjuvant Treatment of Renal Cell Carcinoma SUTENT is indicated for the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. 1.4 Advanced Pancreatic Neuroendocrine Tumors SUTENT is indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease.
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current approval status

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generic names

SUNITINIB MALATE

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l-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease.
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1.4 Advanced Pancreatic Neuroendocrine Tumors SUTENT is indicated for the treatment of progressive, well-di
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Advanced Pancreatic Neuroendocrine Tumors S
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regulatory links

schema version

0.1.0

source batch sha256

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source defined aliases

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exact text: 1.4 Advanced Pancreatic Neuroendocrine Tumors SUTENT is indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease.
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source url

https://api.fda.gov/drug/label.json?search=id%3A%22530eef58-b5ab-49f1-8d73-a2dae0356f24%22

spl effective date

2026-02-20

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

Preserved source evidence · Not medical advice