Cabozantinib (Cometriq)

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 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

Thyroid cancer, differentiated

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. 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 to radioactive iodine (RAI) who have progressed during or after prior systemic therapy 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), not eligible for 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: Cabanib, Cabdual, Cabolong, Cabonrom, Cabotib, Cabotres, Caboxen, Caboxib, Cabozanib, Cabozanix, Cabozat, CabzoRed, Cabometyx, Cazanat, Comarit, Cometriq, Kabonib, Lucicaboz, Lupizotib

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)

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