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# FDA Accepts Bristol-Myers sBLA for Opdivo
- URL: https://www.fdaweb.com/fda-accepts-bristol-myers-sbla-for-opdivo/
- Published: 2017-05-24T12:00:00.000Z
- Updated: 2026-09-14T22:25:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138775

FDA has accepted a Bristol-Myers Squibb supplemental BLA that seeks to extend the use of Opdivo (nivolumab) to patients with hepatocellular carcinoma (HCC) after prior sorafenib therapy. The agency has granted the submission a priority review and previously granted *Opdivo* orphan-drug designation for treating HCC. The user fee review target date is 9/24.

  
The submission was based on data from the Phase 1/2 CheckMate -040 study evaluating Opdivo in advanced HCC patients with and without hepatitis B virus or hepatitis C virus infections. Data from this study were recently published in *The Lancet* and will be presented at the American Society of Clinical Oncology annual meeting 6/2.