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FDA approves Opdivo (nivolumab) to treat advanced renal cell carcinoma- BMS + Ono Pharma

Read time: 1 mins
Last updated:25th Nov 2015
Published:25th Nov 2015
Source: Pharmawand

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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