Posted by Michael Wonder on 16 Apr 2018
U.S. FDA approves Opdivo (nivolumab) + Yervoy (ipilimumab) combination as first-line treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma
16 April 2018 - The Opdivo + low-dose Yervoy combination is the first and only treatment to show significantly superior overall survival versus sunitinib in intermediate- and poor-risk advanced renal cell carcinoma, including a survival benefit regardless of PD-L1 expression.
Bristol-Myers Squibb today announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the U.S. FDA as the first immuno-oncology combination therapy for previously untreated patients with intermediate- and poor-risk advanced renal cell carcinoma. In the Phase 3 CheckMate-214 clinical trial, the Opdivo + Yervoy combination demonstrated a significant and unprecedented increase in overall survival in this patient population compared to a current standard of care, sunitinib. An overall survival benefit was observed regardless of PD-L1 expression level.
