RCC is the most common form of kidney cancer in adults.
The FDA’s priority review and approval of CABOMETYX was based on results from the randomized phase 2 CABOSUN trial in patients with previously untreated RCC, which demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus sunitinib, a current standard of care. Today’s label expansion follows the initial FDA approval of CABOMETYX in April 2016 for the treatment of patients with advanced RCC who have previously received anti-angiogenic therapy.