EMA Action Brings Nivolumab Closer to First Hematology Approval

The European Medicines Agency (EMA) validated an application for use of nivolumab (Opdivo) for previously treated patients with classical Hodgkin lymphoma (cHL), which officially begins the centralized review process for final approval of the drug in the European Union (EU).

The EMA will be evaluating nivolumab primarily based on data from the phase II CheckMate-205 trial, which is evaluating nivolumab in both newly diagnosed and previously treated patients with cHL. Results from the study will likely be presented at a scientific meeting later this year, according to Bristol-Myers Squibb (BMS), the developer of the drug. – See more at: http://global.onclive.com/web-exclusives/ema-action-brings-nivolumab-closer-to-first-hematology-approval#sthash.aR1MWGNf.dpuf