FDA approves Opdivo (nivolumab) to treat advanced renal cell carcinoma- BMS + Ono Pharma
BMS announced that the 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. This 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.
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,(marketed as Afinitor), 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. In the study, the safety profile was consistent with prior Opdivo studies.
Comment: Torisel (temsirolimus) from Pfizer, approved in 2007, is the only other FDA-approved therapy that has demonstrated overall survival in renal cell cancer.
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