Dr. Choueiri on FDA Approval of Cabozantinib for RCC

Toni K. Choueiri, MD
Published: Tuesday, Apr 26, 2016



Toni K. Choueiri, MD, clinical director, Lank Center for Genitourinary Oncology, director, Kidney Cancer Center, senior physician, Dana-Farber Cancer Institute, comments on the FDA approval of cabozantinib (Cabometyx) for treatment of patients with renal cell carcinoma (RCC) in the second-line setting. The indication is for patients who received prior antiangiogenic therapy. 

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

Dose titration and dose escalation with cabozantinib may be necessary, Choueiri says, adding that practitioners should appropriately manage side effects. Adverse events associated with cabozantinib include fatigue and diarrhea.


Toni K. Choueiri, MD, clinical director, Lank Center for Genitourinary Oncology, director, Kidney Cancer Center, senior physician, Dana-Farber Cancer Institute, comments on the FDA approval of cabozantinib (Cabometyx) for treatment of patients with renal cell carcinoma (RCC) in the second-line setting. The indication is for patients who received prior antiangiogenic therapy. 

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

Dose titration and dose escalation with cabozantinib may be necessary, Choueiri says, adding that practitioners should appropriately manage side effects. Adverse events associated with cabozantinib include fatigue and diarrhea.



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