Posted by Michael Wonder on 14 Dec 2017
U.S. FDA accepts Bristol-Myers Squibb’s application for Opdivo (nivolumab) plus Yervoy (ipilimumab) in intermediate and poor-risk patients with advanced renal cell carcinoma and grants priority review
13 December 2017 - The Opdivo plus Yervoy combination previously received FDA breakthrough therapy designation.
Bristol-Myers Squibb Company announced today that the U.S. FDA has accepted its supplemental biologics license application for priority review of Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma. The FDA also previously granted breakthrough therapy designation for this application, which is the second indication for which the Opdivo plus Yervoy combination has received this designation.
The application is based on data from the phase 3 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 recently presented at the European Society for Medical Oncology 2017 Congress.
The application has an action date of 16 April 2018.
