Posted by Michael Wonder on 01 Mar 2022
U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for Opdivo (nivolumab) plus chemotherapy as neo-adjuvant treatment for resectable non-small cell lung cancer
28 February 2022 - Application based on CheckMate-816, the first Phase 3 trial with an immunotherapy-based combination to demonstrate improved event-free survival and pathologic complete response in this setting.
Bristol Myers Squibb today announced that the U.S. FDA has accepted the supplemental Biologics License Application for Opdivo (nivolumab) plus chemotherapy for the neo-adjuvant treatment of patients with resectable non-small cell lung cancer, based on results from the CheckMate -816 trial.
The FDA granted the application priority review status and assigned a Prescription Drug User Fee Act goal date of 13 July 2022.
