FDA and European Medicines Agency accepts for review licence extension application for nivolumab and ipilimumab as first-line treatment of metastatic or recurrent non-small cell lung cancer, with no EGFR or ALK genomic tumour aberrations

The applications are based on data from the Phase III CheckMate-9LA trial, which evaluated nivolumab plus low-dose ipilimumab alongside two cycles of chemotherapy (CT) vs. CT alone, which met its primary endpoint in showing a significant improvement in overall survival.