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Title | Cabometyx (cabozantinib) FDA Drug Label |
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URL | https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208692 |
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Molecular Profile | Treatment Approach |
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Gene Name | Source | Synonyms | Protein Domains | Gene Description | Gene Role |
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Therapy Name | Drugs | Efficacy Evidence | Clinical Trials |
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Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Cabozantinib | Cometriq | Cabometyx|Cabozantinib-s-malate|XL184 | AXL Inhibitor 27 FLT3 Inhibitor 55 KIT Inhibitor 51 MET Inhibitor 51 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 use in patients with medullary thyroid cancer, Cabometyx (cabozantinib) is FDA approved for use in patients with advanced renal cell carcinoma, hepatocellular carcinoma previously treated with sorafenib, and in combination with Opdivo (nivolumab) in patients with advanced renal cell carcinoma (FDA.gov). |
Gene | Variant | Impact | Protein Effect | Variant Description | Associated with drug Resistance |
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Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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Unknown unknown | renal cell carcinoma | not applicable | Cabozantinib + Nivolumab | FDA approved | Actionable | In a Phase III trial (CHECKMATE-9ER) that supported FDA approval, Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) significantly improved median progression-free survival (16.6 vs 8.3 mo, HR 0.51, P < 0.0001), overall survival (HR 0.60, p<0.0010), and objective response rate (55.7% vs 27.1%, P < 0.0001) compared to Sutent (sunitinib) in patients with advanced real cell carcinoma (Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325; NCT03141177). | detail... detail... detail... |
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 (METEOR) 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; NCT01865747). | detail... 26406150 |
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... |
Unknown unknown | renal cell carcinoma | not applicable | Cabozantinib | FDA approved | Actionable | In a Phase II trial (CABOSUN) that supported FDA approval, Cabometyx (cabozantinib) treatment resulted in improved progression free survival (8.2 v 5.6 months) and objective response rate (46% vs 18%) compared to Sutent (sunitinib) in patients with untreated metastatic renal cell carcinoma, with a 34% reduction in rate of progression or death (HR=0.66, p=0.012) (PMID: 28199818; NCT01835158). | 28199818 detail... |