Posted by Michael Wonder on 03 May 2018
EMA validates Bristol-Myers Squibb’s type II variation application for Opdivo plus Yervoy combination for treatment of first-line metastatic non-small-cell lung cancer
3 May 2018 - If approved, Opdivo plus Yervoy would be the first I-O/I-O combination in the EU for first-line metastatic NSCLC patients with tumour mutational burden ≥10 mutations/megabase.
Bristol-Myers Squibb today announced that the EMA validated a type II variation application for the Opdivo (nivolumab) plus Yervoy (ipilimumab) combination for treatment in adult patients with first-line metastatic non-small cell lung cancer (NSCLC) who have tumor mutational burden (TMB) ≥10 mutations/megabase. Validation of the application confirms the submission is complete and begins the EMA’s centralised review process.
The application is based on data from Part 1 of CheckMate-227, a global Phase 3 study evaluating Opdivo-based regimens versus chemotherapy in patients with first-line advanced NSCLC across squamous and non-squamous histologies. Initial results from this study were presented at the American Association for Cancer Research Annual Meeting in April 2018 and simultaneously published in The New England Journal of Medicine.
