NDAORALCAPSULEPriority Review
Approved
Nov 2012
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
Priority Review
COMETRIQ (cabozantinib) by Exelixis is and/or cellular assays have shown that cabozantinib inhibits the tyrosine kinase activity of ret, met, vegfr-1, -2 and -3, kit, trkb, flt-3, axl, ros1, tyro3, mer, and tie-2. First approved in 2012.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COMETRIQ (cabozantinib) is an oral multi-targeted tyrosine kinase inhibitor approved in 2012 that blocks RET, MET, VEGFR, KIT, and other receptor tyrosine kinases involved in oncogenesis and tumor progression. It is indicated for advanced medullary thyroid cancer and other solid tumors where it inhibits pathologic processes including metastasis, angiogenesis, and drug resistance. The drug works by disrupting multiple signaling pathways critical to tumor growth and the tumor microenvironment.
$0.003BPart D
Peak5.6 years to LOEProduct is in peak lifecycle stage with modest Part D utilization (188 claims), indicating a niche but stable franchise with potential for targeted team expansion in medical affairs and commercial operations.
Mechanism of Action
and/or cellular assays have shown that cabozantinib inhibits the tyrosine kinase activity of RET, MET, VEGFR-1, -2 and -3, KIT, TRKB, FLT-3, AXL, ROS1, TYRO3, MER, and TIE-2. These receptor tyrosine kinases are involved in both normal cellular function and pathologic processes such as oncogenesis,…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Study of Cabozantinib With Selumetinib for Plexiform Neurofibromas
Started Aug 2026
30 enrolled
Neurofibromatosis 1Plexiform Neurofibroma
Modulation of the Bone Immune Microenvironment Following Cabozantinib Treatment of Bone Metastatic Clear Cell Renal Cell Carcinoma: Proof of Concept Study
Started Mar 2026
16 enrolled
Clear Cell Renal Cell Carcinoma
A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208)
Started Mar 2026
254 enrolled
Advanced Renal Cell Carcinoma (RCC)
Study of Cabozantinib in Participants With Neuroendocrine Tumors Who Have Already Received Prior Treatment
Started Dec 2025
150 enrolled
Neuroendocrine Tumors
Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
Started Sep 2025
720 enrolled
Metastatic Clear Cell Renal Cell CarcinomaAdvanced Clear Cell Renal Cell Carcinoma
Worked on COMETRIQ at Exelixis? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.