The U.S. Food and Drug Administration approved Exelixis Inc.'s Cabometyx tablets for the expanded indication of patients with advanced renal cell carcinoma.
Renal cell carcinoma is the most common form of kidney cancer in adults.
The expanded approval of the drug is based on results from a phase 2 trial in patients with previously untreated renal cell carcinoma, where the drug showed statistically significant and clinically meaningful improvement in progression-free survival versus current standard of care sunitinib.
Cabometyx, which the agency approved in April 2016 to treat advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy, demonstrated a 52% reduction in the rate of disease progression or death in the trial. Median progression-free survival for the drug was 8.6 months versus 5.3 months for sunitinib.
The FDA has previously granted priority review to the company's supplemental new drug application for Cabometyx.