Setting new standards in information exchange for the pharmaceutical and biotech industry
FDA Grants Priority Review Status for BMS’s Kidney Cancer Combination Therapy
December 15, 2017
Congratulations to Immuno-Oncology 360° speakers, Dr Christine Ward, Dr David Leung and their immuno-oncology team at BMS for receiving priority review to an sBLA for Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma.
According to a BioCentury release, the application was supported by the results of a late-stage study in which the combination therapy achieved the primary endpoints of improving the objective response rate and overall survival versus use of Sutent, or sunitinib. The PDUFA date is scheduled for April 16, 2018.
Dr Christine Ward will be delivering a talk on Tumor Mutation Burden as an Emerging Biomarker and Dr David Leung will be participating on a panel on Operational Aspects for Immunotherapy Imaging at the 4th annual IO360° program taking place February 7-9, 2018 in NYC.
Learn more information about IO360°.