> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Review Extended for sBLA for Opdivo/Yervoy
- URL: https://www.fdaweb.com/review-extended-for-sbla-for-opdivo-yervoy/
- Published: 2018-10-22T12:00:00.000Z
- Updated: 2026-09-15T00:39:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142633

FDA has extended by three months its review of a Bristol-Myers Squibb supplemental BLA for an indication in metastatic first-line non-small cell lung cancer for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) in patients with tumor mutational burden (TMB) greater or equal to 10 mutations/megabase. The company recently submitted an overall survival (OS) analysis for the TMB <10 mut/Mb subgroup, and the agency determined that the submission constituted a major amendment. The new user fee review action target is 5/20/2019.

  
The OS analysis was also submitted to EU reviewers, who have extended their review of a marketing application for the same indication. Both applications are based on data from Part 1 of the ongoing Phase 3 CheckMate -227 trial.