> ## 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.

# FDA Appproves Expanded Use for BMS’ Opdivo/Yervoy
- URL: https://www.fdaweb.com/fda-appproves-expanded-use-for-bms-opdivo-yervoy/
- Published: 2016-01-25T12:00:00.000Z
- Updated: 2026-09-15T02:30:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134544

> FDA has approved a Bristol-Myers Squibb NDA for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for treating patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. The indication was approved under the agency’s accelerated approval program based on progression-free survival (PFS). FDA also expanded the use of Opdivo as a single-agent to include previously untreated BRAF mutation-positive advanced melanoma patients. The drug was approved 11/2015 for use in previously untreated patients with BRAF V600 wild-type unresectable or metastatic melanoma.  
>  
> The expanded approval was based on data from a study called CheckMate -067\. “Median PFS was 11.5 months (95% ci:8.9-16.7) for the Opdivo plus Yervoy regimen and 6.9 months (95% ci:4.3-9.5) for Opdivo monotherapy, vs. 2.9 months (95% ci:2.8-3.4) for Yervoy monotherapy,” the company says.  
>