Arvin Yang, MD, PhD
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of nivolumab (Opdivo) combined with low-dose ipilimumab (Yervoy) as a frontline treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC), according to Bristol-Meyers Squibb (BMS), the developer of both immunotherapy agents.
“There remains a high unmet medical need for patients with advanced renal cell carcinoma,” Arvin Yang, MD, PhD, development lead, melanoma and genitourinary cancers, BMS, said in a statement. “We are encouraged by today’s positive opinion from the CHMP and look forward to potentially bringing the first immuno-oncology combination therapy to appropriate RCC patients across the [European Union].”
The CHMP recommendation is based on findings from the phase III CheckMate-214 trial, which demonstrated that the combination of nivolumab plus ipilimumab led to a 37% reduction in the risk of death versus standard sunitinib (Sutent) in intermediate- and poor-risk patients with advanced RCC, regardless of PD-L1 expression status (HR, 0.63; 99.8% CI, 0.44-0.89; P
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