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.Cabozantinib (Cometriq) package insert Cabozantinib (Cometriq) package insert (locally hosted backup)Cometriq manufacturer's websiteCabozantinib (Cabometyx) package insert Cabozantinib (Cabometyx) package insert (locally hosted backup)Cabometyx manufacturer's website
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.
==Diseases for which it is established (work in progress)==
*Hepatocellular carcinoma
*Medullary thyroid cancer
*Renal cell carcinoma
**Clear cell renal cell carcinoma
**Papillary renal cell carcinoma
*Thyroid cancer, differentiated
==Diseases for which it is used==
*Gastrointestinal stromal tumor
*Neuroendocrine tumor
*Non-small cell lung cancer
*Osteosarcoma
*Pancreatic NET
*Prostate cancer
*Thyroid cancer
==Patient drug information==
*Cabozantinib (Cometriq) package insert pages 20-24 (the numbering for the PDF is off, so in some PDF viewers, the patient information is on pages 27-31)
*Cabozantinib (Cabometyx) package insert
*Cabozantinib (Cometriq) patient drug information (Chemocare)Cabozantinib (Cometriq) patient drug information (Chemocare)
*Cabozantinib (Cometriq) patient drug information (UpToDate)Cabozantinib (Cometriq) patient drug information (UpToDate)
==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==
Category:Drugs
Category:Oral medications
Category:AXL inhibitors
Category:FLT3 inhibitors
Category:KIT inhibitors
Category:MET inhibitors
Category:RET inhibitors
Category:ROS1 inhibitors
Category:TEK inhibitors
Category:TRK inhibitors
Category:VEGFR inhibitors
Category:Gastrointestinal stromal tumor medications
Category:Hepatocellular carcinoma medications
Category:Neuroendocrine tumor medications
Category:Non-small cell lung cancer medications
Category:Osteosarcoma medications
Category:Pancreatic NET medications
Category:Prostate cancer medications
Category:Renal_cell_carcinoma 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:EMA approved in 2014
Category:Health Canada approved in 2018
Category:PMDA approved in 2020