FDA approves Cabometyx for the expanded indication of patients with advanced renal cell carcinoma .- Exelixis.

Exelixis, Inc. announced that the FDA has approved Cabometyx (cabozantinib) tablets for the expanded indication of patients with advanced renal cell carcinoma (RCC). 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 II 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.

According to the independent radiology review committee analysis of the data, Cabometyx demonstrated a clinically meaningful and statistically significant 52 percent reduction in the rate of disease progression or death (HR 0.48, 95% CI 0.31-0.74, two-sided P=0.0008). Median PFS for Cabometyx was 8.6 months versus 5.3 months for sunitinib, corresponding to a 3.3 month (62 percent) improvement.

This 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.