8 May 2018 - - The European Medicines Agency has 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 ≥10 mutations/megabase (mut/Mb), the company said.
Validation of the application confirms the submission is complete and begins the EMA's centralized review process.
The application is based on data from Part 1 of CheckMate -227, a global Phase 3 study evaluating Opdivo-based regimens versus platinum-doublet chemotherapy in patients with first-line advanced non-small cell lung cancer (NSCLC) across non-squamous and squamous tumor histologies.
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