Difference between revisions of "Cabozantinib (Cometriq)"

Revision as of 00:35, 3 April 2023

Note: Cometriq is the brand name for cabozantinib's medullary thyroid cancer indication. Cabometyx is the brand name for cabozantinib's renal cell carcinoma indication.

General information

Class/mechanism: Tyrosine kinase inhibitor; inhibits RET, MET/c-Met, VEGFR-1, VEGFR-2, VEGFR-3, KIT, TRKB, FLT-3, AXL, and TIE-2.^[1]^[2]^[3]^[4]^[5]^[6]
Route: PO
Extravasation: n/a

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.^[1]^[4]

Diseases for which it is established (work in progress)

Diseases for which it is used

Patient drug information

Cabozantinib (Cometriq) package insert pages 20-24^[1] (the numbering for the PDF is off, so in some PDF viewers, the patient information is on pages 27-31)
Cabozantinib (Cabometyx) package insert^[4]
Cabozantinib (Cometriq) patient drug information (Chemocare)^[7]
Cabozantinib (Cometriq) patient drug information (UpToDate)^[8]

History of changes in FDA indication

Differentiated thyroid cancer

2021-09-17: Approved for 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 ineligible or refractory to radioactive iodine. (Based on COSMIC-311)

Hepatocellular carcinoma

2019-01-14: Approved for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. (New disease entity; based on CELESTIAL)

Medullary thyroid cancer

2012-11-29: Initial approval (as Cometriq) for treatment of progressive metastatic medullary thyroid cancer (MTC). (Based on EXAM)

Renal cell carcinoma

2016-04-25: Approved (as Cabometyx) for the treatment of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy. (New disease entity; based on METEOR)
2017-12-19: Granted FDA regular approval for treatment of patients with advanced renal cell carcinoma (RCC). (Converted to regular approval; no longer requires prior treatment; based on CABOSUN)

History of changes in EMA indication

2014-03-21: Initial authorization as Cometriq
2016-09-09: Initial authorization as Cabometyx

History of changes in Health Canada indication

2018-09-14: Initial notice of compliance for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior vascular endothelial growth factor (VEGF)-targeted therapy.
2019-10-10: New indication
2019-11-08: New indication
2021-10-12: New indication
2022-04-28: New indication

Also known as

Code names: XL184, XL-184
Brand names: Cabometyx, Caboxen, Cabozanib, Cabozanix, Cometriq, Lucicaboz

References

[insert-1] 1.0 ^1.1 ^1.2 Cabozantinib (Cometriq) package insert

[2] Cabozantinib (Cometriq) package insert (locally hosted backup)

[3] Cometriq manufacturer's website

[insert_Cabometyx-4] 4.0 ^4.1 ^4.2 Cabozantinib (Cabometyx) package insert

[5] Cabozantinib (Cabometyx) package insert (locally hosted backup)

[6] Cabometyx manufacturer's website

[7] Cabozantinib (Cometriq) patient drug information (Chemocare)

[8] Cabozantinib (Cometriq) patient drug information (UpToDate)

[1]

[2]

[3]

[4]

[5]

[6]

[7]

[8]

@@ Line 29: / Line 29: @@
 ==History of changes in FDA indication==
 ===[[Differentiated thyroid cancer]]===
-*9/17/2021: Approved for adult and pediatric patients 12 years of age and older with locally advanced or metastatic [[Thyroid cancer, differentiated|differentiated thyroid cancer (DTC)]] that has progressed following prior VEGFR-targeted therapy and who are ineligible or refractory to radioactive iodine. ''(Based on COSMIC-311)''
+*2021-09-17: Approved for adult and pediatric patients 12 years of age and older with locally advanced or metastatic [[Thyroid cancer, differentiated|differentiated thyroid cancer (DTC)]] that has progressed following prior VEGFR-targeted therapy and who are ineligible or refractory to radioactive iodine. ''(Based on COSMIC-311)''
 ===[[Hepatocellular carcinoma]]===
-*1/14/2019: Approved for patients with [[Hepatocellular carcinoma|hepatocellular carcinoma (HCC)]] who have been previously treated with [[Sorafenib (Nexavar)|sorafenib]]. ''(New disease entity; based on CELESTIAL)''
+*2019-01-14: Approved for patients with [[Hepatocellular carcinoma|hepatocellular carcinoma (HCC)]] who have been previously treated with [[Sorafenib (Nexavar)|sorafenib]]. ''(New disease entity; based on CELESTIAL)''
 ===[[Medullary thyroid cancer]]===
-*11/29/2012: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm330213.htm Initial approval] (as Cometriq) for treatment of progressive metastatic [[Thyroid cancer, medullary| medullary thyroid cancer (MTC)]]. ''(Based on EXAM)''
+*2012-11-29: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm330213.htm Initial approval] (as Cometriq) for treatment of progressive metastatic [[Thyroid cancer, medullary| medullary thyroid cancer (MTC)]]. ''(Based on EXAM)''
 ===[[Renal cell carcinoma]]===
-*4/25/2016: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm497483.htm Approved] (as Cabometyx) for the treatment of advanced [[Renal_cell_carcinoma|renal cell carcinoma]] in patients who have received prior [[:Category:VEGFR_inhibitors|anti-angiogenic therapy]]. ''(New disease entity; based on METEOR)''
+*2016-04-25: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm497483.htm Approved] (as Cabometyx) for the treatment of advanced [[Renal_cell_carcinoma|renal cell carcinoma]] in patients who have received prior [[:Category:VEGFR_inhibitors|anti-angiogenic therapy]]. ''(New disease entity; based on METEOR)''
-*12/19/2017: Granted FDA regular approval for treatment of patients with advanced [[Renal_cell_carcinoma|renal cell carcinoma (RCC)]]. ''(Converted to regular approval; no longer requires prior treatment; based on CABOSUN)''
+*2017-12-19: Granted FDA regular approval for treatment of patients with advanced [[Renal_cell_carcinoma|renal cell carcinoma (RCC)]]. ''(Converted to regular approval; no longer requires prior treatment; based on CABOSUN)''
 ==History of changes in EMA indication==
-*3/21/2014: Initial authorization as Cometriq
+*2014-03-21: Initial authorization as Cometriq
-*9/9/2016: Initial authorization as Cabometyx
+*2016-09-09: Initial authorization as Cabometyx
+==History of changes in Health Canada indication==
+*2018-09-14: Initial notice of compliance for the treatment of adult patients with advanced [[Renal_cell_carcinoma|renal cell carcinoma (RCC)]] who have received prior vascular endothelial growth factor (VEGF)-targeted therapy.
+*2019-10-10: New indication
+*2019-11-08: New indication
+*2021-10-12: New indication
+*2022-04-28: New indication
 ==Also known as==
@@ Line 74: / Line 80: @@
 [[Category:FDA approved in 2012]]
 [[Category:EMA approved in 2014]]
+[[Category:Health Canada approved in 2018]]