Dr. Choueiri on FDA Approval of Cabozantinib for RCC

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.