New First-Line Kidney Cancer Combination Gets FDA Nod
WASHINGTON — The FDA approved the combination of nivolumab (Opdivo) plus cabozantinib (Cabometyx) on Friday for treating advanced renal cell carcinoma (RCC) in the first-line setting.
Support for approval came from CheckMate-9ER, a phase III trial that randomized 651 previously untreated patients with advanced RCC to either sunitinib (Sutent) alone or the combination of nivolumab, a PD-1-directed checkpoint inhibitor, plus the tyrosine kinase inhibitor cabozantinib, until disease progression or unacceptable toxicity.