Difference between revisions of "Cabozantinib (Cometriq)"

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''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==
 
==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.<ref name="insert">[http://www.cometriq.com/downloads/Cometriq_Full_Prescribing_Information.pdf Cabozantinib (Cometriq) package insert]</ref><ref>[[Media:Cabozantinib.pdf | Cabozantinib (Cometriq) package insert (locally hosted backup)]]</ref><ref>[http://www.cometriq.com/ Cometriq manufacturer's website]</ref><ref name="insert_Cabometyx">[https://www.cabometyx.com/downloads/CABOMETYXUSPI.pdf Cabozantinib (Cabometyx) package insert]</ref><ref>[[Media:Cabozantinib cabometyx.pdf | Cabozantinib (Cabometyx) package insert (locally hosted backup)]]</ref><ref>[https://www.cabometyx.com/ Cabometyx manufacturer's website]</ref>
+
Class/mechanism: Tyrosine kinase inhibitor; inhibits RET, MET/c-Met, VEGFR-1, VEGFR-2, VEGFR-3, KIT, TRKB, FLT-3, AXL, and TIE-2.<ref name="insert">[http://www.cometriq.com/downloads/Cometriq_Full_Prescribing_Information.pdf Cabozantinib (Cometriq) package insert]</ref><ref>[[:File:Cabozantinib.pdf | Cabozantinib (Cometriq) package insert (locally hosted backup)]]</ref><ref>[http://www.cometriq.com/ Cometriq manufacturer's website]</ref><ref name="insert_Cabometyx">[https://www.cabometyx.com/downloads/CABOMETYXUSPI.pdf Cabozantinib (Cabometyx) package insert]</ref><ref>[[:File:Cabozantinib cabometyx.pdf | Cabozantinib (Cabometyx) package insert (locally hosted backup)]]</ref><ref>[https://www.cabometyx.com/ Cabometyx manufacturer's website]</ref>
 
<br>Route: PO
 
<br>Route: PO
 
<br>Extravasation: n/a
 
<br>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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref><ref name="insert_Cabometyx"></ref>
 
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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref><ref name="insert_Cabometyx"></ref>
 +
 +
==Diseases for which it is established ''(work in progress)''==
 +
*[[Differentiated thyroid cancer]]
 +
*[[Hepatocellular carcinoma]]
 +
*[[Medullary thyroid cancer]]
 +
*[[Renal cell carcinoma]]
 +
**[[Clear cell renal cell carcinoma]]
 +
**[[Papillary renal cell carcinoma]]
  
 
==Diseases for which it is used==
 
==Diseases for which it is used==
−
*[[Hepatocellular carcinoma]]
+
*[[Gastrointestinal stromal tumor]]
 
*[[Non-small cell lung cancer]]
 
*[[Non-small cell lung cancer]]
 +
*[[Osteosarcoma]]
 
*[[Prostate cancer]]
 
*[[Prostate cancer]]
−
*[[Renal cell carcinoma]]
+
*[[Thyroid cancer]]
−
*[[Thyroid_cancer#Medullary_thyroid_cancer | Medullary thyroid cancer]]
 
  
 
==Patient drug information==
 
==Patient drug information==
 
*[http://www.cometriq.com/downloads/Cometriq_Full_Prescribing_Information.pdf#page=20 Cabozantinib (Cometriq) package insert pages 20-24]<ref name=insert></ref> (the numbering for the PDF is off, so in some PDF viewers, the patient information is on pages 27-31)
 
*[http://www.cometriq.com/downloads/Cometriq_Full_Prescribing_Information.pdf#page=20 Cabozantinib (Cometriq) package insert pages 20-24]<ref name=insert></ref> (the numbering for the PDF is off, so in some PDF viewers, the patient information is on pages 27-31)
 
*[https://www.cabometyx.com/downloads/CABOMETYXUSPI.pdf Cabozantinib (Cabometyx) package insert]<ref name="insert_Cabometyx"></ref>
 
*[https://www.cabometyx.com/downloads/CABOMETYXUSPI.pdf Cabozantinib (Cabometyx) package insert]<ref name="insert_Cabometyx"></ref>
−
*[http://www.chemocare.com/chemotherapy/drug-info/cabozantinib.aspx Cabozantinib (Cometriq) patient drug information (Chemocare)]<ref>[http://www.chemocare.com/chemotherapy/drug-info/cabozantinib.aspx Cabozantinib (Cometriq) patient drug information (Chemocare)]</ref>
+
*[https://chemocare.com/druginfo/cabozantinib.aspx Cabozantinib (Cometriq) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/cabozantinib.aspx Cabozantinib (Cometriq) patient drug information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/cabozantinib-patient-drug-information Cabozantinib (Cometriq) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/cabozantinib-patient-drug-information Cabozantinib (Cometriq) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/cabozantinib-patient-drug-information Cabozantinib (Cometriq) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/cabozantinib-patient-drug-information Cabozantinib (Cometriq) patient drug information (UpToDate)]</ref>
  
 
==History of changes in FDA indication==
 
==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 [[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]]===
 
===[[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)''
+
*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)''
−
===[[Thyroid_cancer#Medullary_thyroid_cancer | Medullary thyroid cancer]]===
+
===[[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_thyroid_cancer | medullary thyroid cancer (MTC)]].
+
*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]]===
 
===[[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)''
+
*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)''
+
*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==
 +
*2014-03-21: Initial authorization as Cometriq. Cometriq is indicated for the treatment of adult patients with progressive, unresectable locally advanced or metastatic [[Thyroid cancer, medullary|medullary thyroid carcinoma]]. ''(Based on EXAM)''
 +
*2016-09-09: Initial authorization as Cabometyx. Cabometyx is indicated for the treatment of advanced [[renal cell carcinoma|renal cell carcinoma (RCC)]] in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. ''(Based on METEOR)''
 +
*2018-05-08: Extension of indication to include for the treatment of advanced [[renal cell carcinoma]] the ‘treatment-naïve adults with intermediate or poor risk’ for CABOMETYX.
 +
*2018-11-12: Extension of indication to add Cabometyx as monotherapy for the treatment of [[hepatocellular carcinoma]] in adults who have previously been treated with sorafenib.
 +
*2021-03-26: Extension of indication to include in combination with nivolumab first line treatment of advanced [[renal cell carcinoma]] for CABOMETYX.
 +
*2022-04-29: Extension of indication to include monotherapy treatment of adults and adolescent patients aged 12 years and older, with locally advanced or metastatic [[Differentiated thyroid cancer|differentiated thyroid carcinoma (DTC)]], refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy for 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
 +
==History of changes in PMDA indication==
 +
*2020-03-25: Initial approval for the treatment of unresectable or metastatic [[renal cell carcinoma]].
 +
*2020-11-27: New indication for the treatment of unresectable [[hepatocellular carcinoma]] that has progressed after cancer chemotherapy.
  
 
==Also known as==
 
==Also known as==
−
*'''Code names:''' XL184, XL-184
+
*'''Code names:''' XL-184
−
*'''Brand names:''' Cometriq is the brand name for cabozantinib's medullary thyroid cancer indication. Cabometyx is the brand name for cabozantinib's renal cell carcinoma indication.
+
*'''Brand names:''' Cabometyx, Caboxen, Cabozanib, Cabozanix, Cometriq, Lucicaboz
  
 
==References==
 
==References==
Line 37: Line 67:
 
[[Category:Drugs]]
 
[[Category:Drugs]]
 
[[Category:Oral medications]]
 
[[Category:Oral medications]]
−
 
  
 
[[Category:AXL inhibitors]]
 
[[Category:AXL inhibitors]]
Line 49: Line 78:
 
[[Category:VEGFR inhibitors]]
 
[[Category:VEGFR inhibitors]]
  
 +
[[Category:Gastrointestinal stromal tumor medications]]
 
[[Category:Hepatocellular carcinoma medications]]
 
[[Category:Hepatocellular carcinoma medications]]
 
[[Category:Non-small cell lung cancer medications]]
 
[[Category:Non-small cell lung cancer medications]]
 +
[[Category:Osteosarcoma medications]]
 
[[Category:Prostate cancer medications]]
 
[[Category:Prostate cancer medications]]
 
[[Category:Renal_cell_carcinoma medications]]
 
[[Category:Renal_cell_carcinoma medications]]
−
[[Category:Thyroid cancer medications]]
+
[[Category:Clear cell renal cell carcinoma medications]]
 +
[[Category:Papillary renal cell carcinoma medications]]
 +
[[Category:Thyroid cancer, differentiated medications]]
 +
[[Category:Thyroid cancer, medullary medications]]
 
[[Category:FDA approved in 2012]]
 
[[Category:FDA approved in 2012]]
 +
[[Category:EMA approved in 2014]]
 +
[[Category:Health Canada approved in 2018]]
 +
[[Category:PMDA approved in 2020]]

Latest revision as of 18:14, 6 November 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

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

Medullary thyroid cancer

Renal cell carcinoma

History of changes in EMA indication

  • 2014-03-21: Initial authorization as Cometriq. Cometriq is indicated for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma. (Based on EXAM)
  • 2016-09-09: Initial authorization as Cabometyx. Cabometyx is indicated for the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. (Based on METEOR)
  • 2018-05-08: Extension of indication to include for the treatment of advanced renal cell carcinoma the ‘treatment-naïve adults with intermediate or poor risk’ for CABOMETYX.
  • 2018-11-12: Extension of indication to add Cabometyx as monotherapy for the treatment of hepatocellular carcinoma in adults who have previously been treated with sorafenib.
  • 2021-03-26: Extension of indication to include in combination with nivolumab first line treatment of advanced renal cell carcinoma for CABOMETYX.
  • 2022-04-29: Extension of indication to include monotherapy treatment of adults and adolescent patients aged 12 years and older, with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy for 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

History of changes in PMDA indication

  • 2020-03-25: Initial approval for the treatment of unresectable or metastatic renal cell carcinoma.
  • 2020-11-27: New indication for the treatment of unresectable hepatocellular carcinoma that has progressed after cancer chemotherapy.

Also known as

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

References

  1. ↑ 1.0 1.1 1.2 Cabozantinib (Cometriq) package insert
  2. ↑ Cabozantinib (Cometriq) package insert (locally hosted backup)
  3. ↑ Cometriq manufacturer's website
  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)
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