EMA Validates BMY's Type II Application For Opdivo Plus Yervoy Combination

(RTTNews) - Bristol-Myers Squibb Company (BMY) said that the European Medicines Agency or EMA validated a type II variation application for the Opdivo or nivolumab plus Yervoy or ipilimumab combination for treatment in adult patients with first-line metastatic non-small cell lung cancer or NSCLC who have tumor mutational burden (TMB) =10 mutations/megabase (mut/Mb).

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 chemotherapy in patients with first-line advanced NSCLC across squamous and non-squamous histologies.