PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.1 Today’s announcement marks the approval of the first and only PD-1 inhibitor to deliver significant overall survival (OS) in patients with advanced RCC who have received prior anti-angiogenic therapy.1 In the CheckMate -025 trial, patients treated with Opdivo achieved a median OS of 25 months (95% CI: 21.7-not estimable [NE]) versus 19.6 months (95% CI: 17.6-23.1) for everolimus, a current standard of care (SOC) in this patient population (hazard ratio [HR]: 0.73; [95% CI: 0.60-0.89; p=0.0018]), based on a prespecified interim analysis.1,2 In the study, the safety profile was consistent with prior Opdivo studies.2
