Study results presented at ESMO lead to expanded indications for Opdivo

BMS announced that the European Medicines Agency (EMA) validated its type II variation application, which seeks to expand the current indications for Opdivo (nivolumab) plus Yervoy (ipilimumab) to include the treatment of intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC).

Validation of the application confirms the submission is complete and begins the EMA’s centralized review process. The application is based on data from the phase III CheckMate -214 study, which was stopped early based on the recommendation of an independent Data Monitoring Committee following a planned interim analysis of overall survival. The results of the study were presented at the European Society for Medical Oncology (ESMO) 2017 Congress.