> ## 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.

# BMS Files 2 sBLAs for Opdivo/Yervoy
- URL: https://www.fdaweb.com/bms-files-2-sblas-for-opdivo-yervoy/
- Published: 2021-09-27T12:00:00.000Z
- Updated: 2026-09-14T17:16:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150224

FDA has accepted for review two Bristol Myers Squibb supplemental BLAs for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) and Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatments for adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma. The agency has set a user fee review action target date of 5/28/2022.

The submissions are based on data from the Phase 3 CheckMate-648 trial. The data show that both combinations “demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared to chemotherapy in patients with unresectable advanced or metastatic ESCC with tumor cell PD-L1 expression equal to greater than 1%...,” the company says. The safety profiles were also consistent with the known safety profiles of the individual components, it says.

Bristol Myers says Opdivo is a programmed death-1 immune checkpoint inhibitor that is “designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response." Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4, which is a negative regulator of T-cell activity, it says.