EMA Validates BMS’s type II variation application for Opdivo (nivolumab) in previously treated advanced renal cell carcinoma

Overall survival results from CheckMate -025, a landmark Phase 3 study comparing Opdivo versus everolimus in this patient population, serves as basis for application.

Michael Giordano, senior vice president, head of Development, Oncology, BMS, commented, “Europe has one of the highest incidence rates of renal cell carcinoma, and a significant percentage of these patients are diagnosed at an advanced stage of the disease. The validation of our application by the EMA is an important step in the regulatory review process in the European Union, and we will continue to work with the utmost speed to bring Opdivo to patients with this cancer.”

The type II variation submitted is based on data from CheckMate -025, a Phase III study that evaluated, as the primary endpoint, the overall survival of Opdivo versus everolimus, a current standard of care, in advanced or metastatic clear-cell RCC after prior anti-angiogenic treatment. Results from CheckMate -025 were recently presented at the 2015 European Cancer Congress, and published in The New England Journal of Medicine.