Posted by Michael Wonder on 21 Jun 2018
U.S. FDA accepts application for Opdivo plus low-dose Yervoy for treatment of first-line non-small cell lung cancer in patients with tumour mutational burden ≥10 mut/Mb
21 June 2018 - First-ever application for an I-O/I-O combination in lung cancer to be accepted.
Bristol-Myers Squibb Company announced today that the U.S. FDA has accepted its supplemental biologics license application for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) for the treatment of first-line advanced non-small cell lung cancer (NSCLC) in patients with tumour mutational burden (TMB) ≥10 mutations per megabase (mut/Mb). The target FDA action date is 20 February 2019.
The application was based on results from Part 1 of CheckMate -227, the first and only global Phase 3 study to evaluate an I-O/I-O regimen versus chemotherapy in a population of first-line NSCLC patients with TMB ≥10 mut/Mb, across squamous and non-squamous tumor histologies and the PD-L1 expression spectrum. These data were presented at the American Association for Cancer Research Annual Meeting 2018 and published in The New England Journal of Medicine.
