EMA validates application for Opdivo (nivolumab) to treatclassical Hodgkin lymphoma.- BMS

Bristol-Myers Squibb Company announced that the European Medicines Agency (EMA) validated a type II variation application, which seeks to extend the current indications for Opdivo (nivolumab) to include the treatment of patients with classical Hodgkin lymphoma (cHL) after prior therapies. The application included CheckMate 205 data, which evaluated Opdivo in cHL patients who have received autologous stem cell transplant and brentuximab vedotin. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.

CheckMate 205 is a Phase II study evaluating the safety and efficacy of Opdivo in patients with relapsed or refractory cHL. The results of this trial are expected to be presented at a medical meeting later this year.