The FDA approved nivolumab (Opdivo, Bristol Myers Squibb) in combination with cabozantinib (Cabometyx, Exelixis) for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
The approval is based on the phase 3 CheckMate 9ER trial, which compared nivolumab in combination with cabozantinib (n=323) versus sunitinib (Sutent, Pfizer; n=328) in patients with advanced RCC. Patients were randomized to receive 240 mg of nivolumab every two weeks intravenously and 40 mg of