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# FDA Gives BMS ‘Breakthrough’ Status for Opdivo
- URL: https://www.fdaweb.com/fda-gives-bms-breakthrough-status-for-opdivo/
- Published: 2016-04-25T12:00:00.000Z
- Updated: 2026-09-14T20:57:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135479

> FDA has granted Bristol-Myers Squibb a breakthrough therapy designation for Opdivofor treating recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after platinum based therapy. The designation is based on results from the CheckMate-141 study, a Phase 3, open-label, randomized trial evaluating Opdivoversus investigator’s choice of therapy in patients with recurrent or metastatic SCCHN with tumor progression within six months of platinum therapies in the adjuvant, primary, recurrent or metastatic setting. The trial was stopped early in January after an assessment conducted by an independent data monitoring committee concluded that the study met its primary endpoint of overall survival, the company says.