Reference Detail

Contact

Missing content? – Request curation!

Request curation for specific Genes, variants, or PubMed publications.

Have questions, comments or suggestions? - Let us know!

Email us at : ckbsupport@jax.org

Ref Type
PMID
Authors
Title Cabometyx (cabozantinib) FDA Drug Label
Journal
Vol
Issue
Date
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208692
Abstract Text

Filtering

  • Case insensitive filtering will display rows where any text in any cell matches the filter term
  • Simple literal full or partial string matches
  • Separate multiple filter terms with a spaces, order doesn't matter (a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page, filtering has no impact on query parameters
  • Use quotes to match a longer phrase which contains spaces "mtor c1483f"

Sorting

  • Generally, the default sort order for tables is set to be first column ascending, however, specific tables may set a different default sort order.
  • Click on any column header arrows to sort by that column
  • Hold down the Shift key and click multiple columns to sort by more than one column, be sure to set ascending or descending order for a given column, before moving on to the next column.

Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Cabozantinib Cometriq Cabometyx|Cabozantinib-s-malate|XL184 AXL Inhibitor 27 FLT3 Inhibitor 54 KIT Inhibitor 50 MET Inhibitor 52 RET Inhibitor 39 ROS1 Inhibitor 14 VEGFR2 Inhibitor 35 Cometriq (Cabometyx, cabozantinib) inhibits several receptor tyrosine kinases, including VEGFR2, FLT3, AXL, MET, RET, ROS1 fusions, and c-KIT (PMID: 27370605, PMID: 21926191). Cometriq (cabozantinib) is FDA approved for medullary thyroid cancer and Cabometyx (cabozantinib) is FDA approved for advanced renal cell carcinoma and in sorafenib previously treated hepatocellular carcinoma (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown hepatocellular carcinoma not applicable Cabozantinib FDA approved Actionable In a Phase III trial (CELESTIAL) that supported FDA approval, Cabometyx (cabozantinib) significantly improved overall survival (10.2 vs 8.0 months, HR=0.76, p=0.005) and progression-free survival (5.2 vs 1.9 months, HR=0.44, p<0.001) compared to placebo in patients with previously treated advanced hepatocellular carcinoma (PMID: 29972759; NCT01908426). 29972759 detail...
Unknown unknown renal cell carcinoma not applicable Cabozantinib FDA approved Actionable In a Phase III clinical trial that supported FDA approval, treatment with Cabometyx (cabozantinib) resulted in a median progression-free survival of 7.4 months in patients with renal cell carcinoma, compared to 3.8 months with Afinitor (everolimus), and an objective response rate of 22% (17/76) versus 3% (2/77) with Afinitor (everolimus) (PMID: 26406150). detail... 26406150
Unknown unknown renal cell carcinoma not applicable Cabozantinib Phase II Actionable In a Phase II trial, Cabometyx (cabozantinib) treatment demonstrated improved median progression-free survival (8.2 vs 5.6 months) and overall response rate (46% vs 18%) over Sutent (sunitinib) in untreated patients with metastatic renal cell carcinoma (ESMO 2016 Congress in Copenhagen, Abstract LBA30_PR). detail... detail...
Unknown unknown renal cell carcinoma not applicable Cabozantinib FDA approved Actionable In a Phase III trial, final results extending those that supported FDA approval demonstrated Cabometyx (cabozantinib) improved median overall survival compared to Afinitor (everolimus) (21.4 m vs. 16.5 m) and progression-free survival (7.4 m vs. 3.9 m), and led to a 17% (57/330) objective response rate vs. 3% (11/328) with Afinitor (everolimus) in renal cell carcinoma patients (PMID: 27279544). 27279544 detail...