Posted by Michael Wonder on 08 Apr 2020
Bristol Myers Squibb announces acceptance of U.S. and EU regulatory filings for Opdivo (nivolumab) plus Yervoy (ipilimumab) combined with limited chemotherapy in first-line lung cancer
8 April 2020 - Submissions based on results from Phase 3 CheckMate-9LA trial.
Bristol Myers Squibb today announced that the U.S. FDA has accepted its supplemental biologics license application for Opdivo (nivolumab) plus Yervoy (ipilimumab), administered concomitantly with a limited course of chemotherapy, 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 granted this application priority review with a Prescription Drug User Fee Act goal date of 6 August 2020, in addition to granting fast track designation.
Additionally, the European Medicines Agency validated a type II variation application for Opdivo plus Yervoy, combined with limited chemotherapy, for the same indication.
