30 March 2016 - Bristol-Myers Squibb Company announced today that the EMA validated a type II variation application, which seeks to extend the current indications for Opdivo 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.
For more details, go to: http://news.bms.com/press-release/european-medicines-agency-validates-bristol-myers-squibbs-application-opdivo-nivolumab