Bristol Myers Squibb Receives FDA Approval for Opdivo in Adjuvant Renal Cell Carcinoma

Bristol Myers Squibb today announced that the FDA has approved Opdivo (nivolumab) as adjuvant treatment for adults with renal cell carcinoma (RCC) at high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. In the Phase 3 CheckMate-914 trial, Opdivo demonstrated a statistically significant improvement in disease-free survival compared to placebo. The 2-year DFS rate was 76.4% for Opdivo versus 70.0% for placebo. This approval provides patients with high-risk RCC a new adjuvant treatment option to reduce the risk of cancer recurrence after surgery.