EMA validates application for Opdivo (nivolumab) to treat advanced renal cell carcinoma- BMS

BMS announced that the European Medicines Agency (EMA) validated a type II variation application, which seeks to extend the current indication for Opdivo (nivolumab) to include the treatment of adult patients with advanced renal cell carcinoma (RCC) after prior therapy. Validation of the application confirms the submission is complete and begins the EMA’s centralised review process.

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.