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# BeiGene’s Tevimbra First-Line Use ‘Deferred’
- URL: https://www.fdaweb.com/beigenes-tevimbra-first-line-use-deferred/
- Published: 2024-08-07T12:00:00.000Z
- Updated: 2026-09-14T14:37:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157526

BeiGene says FDA has “deferred approval” for Tevimbra (tislelizumab) in first-line unresectable, recurrent, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) because of a delay in scheduling clinical site inspections. The submission had a July user fee review action date that was missed, and there is no time estimate on when the inspections will be scheduled. Currently, Tevimbra is approved for second-line treatment of ESCC after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.