Posted by Michael Wonder on 14 Apr 2016
U.S. FDA accepts for priority review Bristol-Myers Squibb’s supplemental biologics license application for Opdivo (nivolumab) for the treatment of classical Hodgkin's lymphoma patients
14 April 2016 - Bristol-Myers Squibb Company announced today that the U.S. FDA accepted a supplemental biologics license application which seeks to expand the use of Opdivo to patients with classical Hodgkin's 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. The FDA granted the application a priority review and previously granted Opdivo Breakthrough Therapy Designation for cHL on 14 May 2014.
For more details, go to: http://news.bms.com/press-release/biologics/us-food-and-drug-administration-accepts-priority-review-bristol-myers-squibb
