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FDA Approves Cabozantinib for Renal Cell Carcinoma

Shirish Gadgeel, MD

Toni Choueiri, MD

The FDA has approved cabozantinib (Cabometyx) as a treatment for patients with advanced renal cell carcinoma (RCC) who have received prior antiangiogenic therapy.

The approval was based on findings from the 658-patient phase III METEOR trial, in which the multikinase inhibitor cabozantinib demonstrated a 42% reduction in the risk of progression or death compared with everolimus (Afinitor) in patients with advanced RCC. After a minimum of 11 months of follow-up, median progression-free survival (PFS) with cabozantinib was 7.4 months compared with 3.8 months with everolimus (HR, 0.58; 95% CI, 0.45-0.75; P <.001).

Cabozantinib also reduced the risk of death by 34% in the intent-to-treat population. Median overall survival was 21.4 months for patients receiving cabozantinib versus 16.5 months for those receiving everolimus (HR, 0.66; 95% CI 0.53-0.83; P = .0003). Click here to read the full article at

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