1 1,2 as a standard of care for intermediate- or poor-risk patients 3 OPDIVO ® (nivolumab) 240 mg (injection for intravenous use) every two weeks or 480 mg every four weeks in combination with CABOMETYX ® (cabozantinib) 40 mg once daily tablets was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). 1 The approval is based on the Phase 3 CheckMate -9ER trial, which compared OPDIVO in combination with CABOMETYX (n=323) versus sunitinib (n=328) in patients with advanced RCC. 1 This application was reviewed under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.