Cabozantinib gets FDA nod for advanced HCC


  • Jim Kling
  • Oncology drug update
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Takeaway

  • The U.S. Food and Drug Administration (FDA) has approved cabozantinib for patients with hepatocellular carcinoma (HCC) who were previously treated with sorafenib.

Why this matters

  • Cabozantinib inhibits VEGF receptors 1, 2, and 3, and the receptor tyrosine kinases MET and AXL. MET and AXL are associated with poor outcomes and MET expression may be increased following sorafenib exposure.

Key points

  • The approval was based on results from the CELESTIAL trial:
    • 707 patients with HCC who were previously treated with sorafenib and had Child Pugh Class A liver impairment were randomized 2:1 to cabozantinib 60 mg orally once daily or placebo.
    • Median OS: 10.2 months versus 8.0 months in placebo (HR, 0.76; P=.0049).
    • Median progression free survival was 5.2 months versus 1.9 months for placebo (HR, 0.44; P<.001>
    • Objective response rate: 4% versus 0.4%.
  • Adverse events occurring in at least 25% of patients taking cabozantinib (by highest frequency): diarrhea, fatigue, decreased appetite, palmar-plantar erythrodysesthesia, nausea, hypertension, and vomiting.
  • Recommended cabozantinib dose: 60 mg orally, once daily at least 1 hour before or 2 hours after eating.

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