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Nivolumab/Ipilimumab Combo Nears EU Approval for Frontline RCC

Gina Columbus
Published: Friday, Nov 16, 2018

Arvin Yang, MD, PhD

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 <.0001).

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Online CME Activities
TitleExpiration DateCME Credits
Oncology Briefings™: Individualizing Treatment After Second-Line Therapy for Patients With mCRCAug 29, 20191.0
Community Practice Connections™: Immunotherapeutic Strategies with the Potential to Transform Treatment for Genitourinary CancersAug 29, 20191.0
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