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# FDA Accepts Opdivo sNDA for New Indication
- URL: https://www.fdaweb.com/fda-accepts-opdivo-snda-for-new-indication/
- Published: 2024-02-08T12:00:00.000Z
- Updated: 2026-09-14T14:22:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156324

FDA has accepted a Bristol Myers Squibb sNDA for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage 2A to 3B non-small cell lung cancer. The agency set a PDUFA action date on the sNDA of 10/8, a Bristol Myers Squibb [statement](https://news.bms.com/news/corporate-financial/2024/Bristol-Myers-Squibb-Announces-Acceptance-of-U.S.-and-EU-Regulatory-Filings-for-Neoadjuvant-Opdivo-nivolumab-and-Chemotherapy-Followed-by-Surgery-and-Adjuvant-Opdivo-in-Resectable-Non-Small-Cell-Lung-Cancer/default.aspx?ref=fdaweb.com) says.

The company says its submission was based on results from the Phase 3 CheckMate-771 trial.

Opdivo is described as a programmed death-1 immune checkpoint inhibitor that is designed to uniquely harness the body’s immune system to help restore anti-tumor immune response.