> ## 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 Accepts 2 Opdivo sBLAs for New Indications
- URL: https://www.fdaweb.com/fda-accepts-2-opdivo-sblas-for-new-indications/
- Published: 2021-01-21T12:00:00.000Z
- Updated: 2026-09-14T16:43:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148501

FDA has accepted two Bristol-Myers Squibb sBLAs for new indications for its Opdivo (nivolumab). The first sBLA is to treat patients with resected esophageal or gastroesophageal junction cancer in the adjuvant setting, after neoadjuvant chemoradiation therapy. The agency granted the application priority review and set a PDUFA goal date of 5/20.

The company [says](https://news.bms.com/news/corporate-financial/2021/U.S.-Food-and-Drug-Administration-Accepts-for-Priority-Review-Application-for-Opdivo-nivolumab-as-Adjuvant-Therapy-for-Patients-with-Resected-Esophageal-or-Gastroesophageal-Junction-Cancer/default.aspx?ref=fdaweb.com) its filing was based on results from the Phase 3 CheckMate-577 trial, the first trial to show positive results in the adjuvant setting in this group of patients. The study met its primary endpoint of disease-free survival in patients with the two types of cancer.

The [second](https://news.bms.com/news/corporate-financial/2021/U.S.-Food-and-Drug-Administration-Accepts-for-Priority-Review-Application-for-Opdivo-nivolumab-Combined-with-Chemotherapy-as-First-Line-Treatment-in-Metastatic-Gastric-Cancer-Gastroesophageal-Junction-Cancer-and-Esophageal-Adenocarcinoma/default.aspx?ref=fdaweb.com) sBLA was for Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy to treat patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma. This application also was granted priority review and has a PDUFA goal date of 5/25\. This submission was based on data from the CheckMate-649 Phase 3 trial, BMS says.