TriangleLABELS · e8cdcbdc-d863-4d48-af3e-a8926b9ab017
CABOMETYX
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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.
- Label effective date
- 2025-10-19
- Captured
- 2026-09-09T23:38:02.384588+00:00
- Current indication reconciliation
- Not reconciled
Indications and usage: exact source text
- 1 INDICATIONS AND USAGE CABOMETYX is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab ( 1.1 ) patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib ( 1.2 ) adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible ( 1.3 ) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET). ( 1.4 ) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET). ( 1.4 ) 1.1 Renal Cell Carcinoma CABOMETYX is indicated for the treatment of patients with advanced renal cell carcinoma (RCC). CABOMETYX, in combination with nivolumab, is indicated for the first-line treatment of patients with advanced RCC. 1.2 Hepatocellular Carcinoma CABOMETYX is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. 1.3 Differentiated Thyroid Cancer CABOMETYX is indicated for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible. 1.4 Neuroendocrine Tumors CABOMETYX is indicated for the treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET). CABOMETYX is indicated for the treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET).
Full extracted label fields
- application numbers
- NDA208692
- boxed warning exact
- brand names
- CABOMETYX
- current indication status
- not_reconciled
- dailymed set url
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3850cce2-6137-42e5-a792-d318c4a4b3b5
- generic names
- CABOZANTINIB
- id
- e8cdcbdc-d863-4d48-af3e-a8926b9ab017
- indications and usage exact
- 1 INDICATIONS AND USAGE CABOMETYX is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab ( 1.1 ) patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib ( 1.2 ) adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible ( 1.3 ) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET). ( 1.4 ) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET). ( 1.4 ) 1.1 Renal Cell Carcinoma CABOMETYX is indicated for the treatment of patients with advanced renal cell carcinoma (RCC). CABOMETYX, in combination with nivolumab, is indicated for the first-line treatment of patients with advanced RCC. 1.2 Hepatocellular Carcinoma CABOMETYX is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. 1.3 Differentiated Thyroid Cancer CABOMETYX is indicated for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible. 1.4 Neuroendocrine Tumors CABOMETYX is indicated for the treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET). CABOMETYX is indicated for the treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET).
- indications and usage tables exact
- is original packager
- true
- manufacturer names
- Exelixis, Inc.
- matched search terms
- cancer
- carcinoma
- tumors
- package ndcs
- 42388-023-26
- 42388-023-46
- 42388-023-36
- 42388-023-37
- 42388-023-57
- 42388-025-26
- 42388-025-46
- 42388-025-37
- 42388-025-57
- 42388-024-26
- 42388-024-46
- 42388-024-37
- product ndcs
- 42388-023
- 42388-025
- 42388-024
- product types
- HUMAN PRESCRIPTION DRUG
- recent major changes exact
- Indications and Usage, Neuroendocrine Tumors ( 1.4 ) 03/2025 Dosage and Administration, Recommended Dosage for NET ( 2.4 ) 03/2025 Warnings and Precautions ( 5.4 ) 03/2025 Dosage and Administration, Recommended Dosage ( 2.2 ) 09/2025 Warnings and Precautions ( 5.5 ) 10/2025
- record type
- complete_spl_indications_section_candidate
- routes
- ORAL
- rxcuis
- 1790161
- 1790167
- 1790169
- 1790171
- 1790173
- 1790175
- source batch
- file
- /private/tmp/cancer-full-research/indications/raw/labels-00700.json
- meta
- disclaimer
- Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
- last updated
- 2026-09-09
- results
- limit
- 100
- skip
- 700
- total
- 830
- sha256
- 24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
- source url
- https://api.fda.gov/drug/label.json?search=id%3A%22e8cdcbdc-d863-4d48-af3e-a8926b9ab017%22
- spl effective date
- 2025-10-19
- spl effective time
- 20251019
- spl set id
- 3850cce2-6137-42e5-a792-d318c4a4b3b5
- spl version
- 18
- substance names
- CABOZANTINIB S-MALATE
- uniis
- DR7ST46X58
- verification flags
- oncology_keyword_candidate_not_clinically_classified
- spl_text_not_verified_identical_to_latest_approved_label
- individual_indications_not_split_or_reconciled
Drugs@FDA application source records
- application number
- NDA208692
- payload
- all indexed label documents
- Appl No
- 208692
- Application Docs Date
- 2016-04-25 00:00:00
- Application Docs ID
- 40637
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208692s000lbl.pdf
- Submission No
- 1
- Submission Type
- ORIG
- Appl No
- 208692
- Application Docs Date
- 2017-12-19 00:00:00
- Application Docs ID
- 50776
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208692s002lbl.pdf
- Submission No
- 2
- Submission Type
- SUPPL
- Appl No
- 208692
- Application Docs Date
- 2019-01-15 00:00:00
- Application Docs ID
- 57217
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208692s003lbl.pdf
- Submission No
- 3
- Submission Type
- SUPPL
- Appl No
- 208692
- Application Docs Date
- 2020-02-03 00:00:00
- Application Docs ID
- 61758
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208692s007lbl.pdf
- Submission No
- 7
- Submission Type
- SUPPL
- Appl No
- 208692
- Application Docs Date
- 2020-07-17 00:00:00
- Application Docs ID
- 63945
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208692s008lbl.pdf
- Submission No
- 8
- Submission Type
- SUPPL
- Appl No
- 208692
- Application Docs Date
- 2021-01-22 00:00:00
- Application Docs ID
- 65959
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208692s010lbl.pdf
- Submission No
- 10
- Submission Type
- SUPPL
- Appl No
- 208692
- Application Docs Date
- 2021-04-07 00:00:00
- Application Docs ID
- 66996
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208692Orig1s009lbl.pdf
- Submission No
- 9
- Submission Type
- SUPPL
- Appl No
- 208692
- Application Docs Date
- 2021-09-20 00:00:00
- Application Docs ID
- 68657
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208692s012lbl.pdf
- Submission No
- 12
- Submission Type
- SUPPL
- Appl No
- 208692
- Application Docs Date
- 2022-07-15 00:00:00
- Application Docs ID
- 71569
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208692s014lbl.pdf
- Submission No
- 14
- Submission Type
- SUPPL
- Appl No
- 208692
- Application Docs Date
- 2023-02-15 00:00:00
- Application Docs ID
- 73505
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208692Orig1s013lbl.pdf
- Submission No
- 13
- Submission Type
- SUPPL
- Appl No
- 208692
- Application Docs Date
- 2023-09-21 00:00:00
- Application Docs ID
- 75528
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208692s016lbl.pdf
- Submission No
- 16
- Submission Type
- SUPPL
- Appl No
- 208692
- Application Docs Date
- 2025-03-26 00:00:00
- Application Docs ID
- 81733
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208692s017lbl.pdf
- Submission No
- 17
- Submission Type
- SUPPL
- all submission records
- Appl No
- 208692
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
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- 19
- Submission Status
- AP
- Submission Status Date
- 2025-10-09 00:00:00
- Submission Type
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- Submissions Public Notes
- Appl No
- 208692
- Review Priority
- STANDARD
- Submission Class Code ID
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- Submission No
- 18
- Submission Status
- AP
- Submission Status Date
- 2025-09-10 00:00:00
- Submission Type
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- Submissions Public Notes
- Appl No
- 208692
- Review Priority
- STANDARD
- Submission Class Code ID
- 2
- Submission No
- 17
- Submission Status
- AP
- Submission Status Date
- 2025-03-26 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208692
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 16
- Submission Status
- AP
- Submission Status Date
- 2023-09-20 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208692
- Review Priority
- STANDARD
- Submission Class Code ID
- 2
- Submission No
- 14
- Submission Status
- AP
- Submission Status Date
- 2022-07-14 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208692
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 13
- Submission Status
- AP
- Submission Status Date
- 2023-02-13 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208692
- Review Priority
- PRIORITY
- Submission Class Code ID
- 2
- Submission No
- 12
- Submission Status
- AP
- Submission Status Date
- 2021-09-17 00:00:00
- Submission Type
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- Appl No
- 208692
- Review Priority
- PRIORITY
- Submission Class Code ID
- 2
- Submission No
- 10
- Submission Status
- AP
- Submission Status Date
- 2021-01-22 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208692
- Review Priority
- N/A
- Submission Class Code ID
- 4
- Submission No
- 9
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- Submission Status Date
- 2020-11-05 00:00:00
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- Appl No
- 208692
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- 3
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- 8
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- Submission Status Date
- 2020-07-16 00:00:00
- Submission Type
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- Submissions Public Notes
- Appl No
- 208692
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 7
- Submission Status
- AP
- Submission Status Date
- 2020-01-31 00:00:00
- Submission Type
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- Appl No
- 208692
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- Submission Class Code ID
- 2
- Submission No
- 3
- Submission Status
- AP
- Submission Status Date
- 2019-01-14 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- application number
- NDA208692
- approval interpretation
- Application linkage and approved submission are not indication-level current approval verification
- current indication status
- not_reconciled
- drugsfda url
- https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208692
- has approved submission record
- true
- latest approved submission date
- 2025-10-09
- latest label selection rule
- max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
- latest posted label documents
- Appl No
- 208692
- Application Docs Date
- 2025-10-09 00:00:00
- Application Docs ID
- 83713
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208692s019lbl.pdf
- Submission No
- 19
- Submission Type
- SUPPL
- official application record
- Appl No
- 208692
- Appl Public Notes
- Appl Type
- NDA
- Sponsor Name
- EXELIXIS INC
- openfda application present
- true
- products
- Active Ingredient
- CABOZANTINIB S-MALATE
- Appl No
- 208692
- Drug Name
- CABOMETYX
- Form
- TABLET;ORAL
- Product No
- 001
- Reference Drug
- 1
- Reference Standard
- 0
- Strength
- EQ 20MG BASE
- marketing status
- Prescription
- Active Ingredient
- CABOZANTINIB S-MALATE
- Appl No
- 208692
- Drug Name
- CABOMETYX
- Form
- TABLET;ORAL
- Product No
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- 1
- Reference Standard
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- Strength
- EQ 40MG BASE
- marketing status
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- Active Ingredient
- CABOZANTINIB S-MALATE
- Appl No
- 208692
- Drug Name
- CABOMETYX
- Form
- TABLET;ORAL
- Product No
- 003
- Reference Drug
- 1
- Reference Standard
- 1
- Strength
- EQ 60MG BASE
- marketing status
- Prescription
Source passages and status connections
Passage 1 · positive indication candidate
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- 1 INDICATIONS AND USAGE CABOMETYX is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab ( 1.1 ) patients with hepatocellular carcinoma (HCC) who have been previously treated with
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Passage 2 · unclassified context
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- 1 INDICATIONS AND USAGE CABOMETYX is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab ( 1.1 ) patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafen
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- 1 INDICATIONS AND USAGE CABOMETYX is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab ( 1.1 ) patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib ( 1.2 ) adult and pediatric patients 12 years of age and older with locally advanced or metastatic differe
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Preserved source evidence · Not medical advice