Bristol-Myers Squibb Receives CHMP Recommendation for Opdivo (nivolumab) + Low-Dose Yervoy (ipilimumab) in 1L RCC Based in P-III CheckMate-214 study

Shots:

• CHMP recommendation is based on the results of P-III CheckMate-214 study assessing Opdivo 3 mg/kg (q3w @four doses, q2w) + Yervoy 1 mg/kg vs sunitinib (50 mg qd @four weeks) in ~900 patients with 1L intermediate- and poor-risk advanced renal cell carcinoma (RCC)
• P-III CheckMate-214 study results: increase in OS; 37% reduction in death of patients; DRR (41.6% vs 26.5%); no new safety signals observed
• Opdivo is a PD-1 immune checkpoint inhibitor involved in fighting against cancer cells and is approved in >65 countries including the US, EU, Japan, China

Click here to read full press release/ article | Ref: Bristol-Myers Squibb | Image: New Drug Approvals