Posted by Michael Wonder on 15 Jan 2020
U.S. FDA accepts for priority review Bristol-Myers Squibb’s application for Opdivo (nivolumab) plus Yervoy (ipilimumab) in first-line non-small cell lung cancer
15 January 2020 - Application based on results from Part 1 of Phase 3 CheckMate-227 study.
Bristol-Myers Squibb today announced the U.S. FDA has accepted its supplemental biologics license application for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumour aberrations.
The FDA has granted the application Priority Review with a Prescription Drug User Fee Act goal date of 15 May 2020.
