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Treats unresectable or metastatic esophageal squamous cell carcinoma (ESCC). Sold as Tevimbra. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 2 applications for Tislelizumab-Jsgr (sold as Tevimbra), first approved Mar 13, 2024, with 10 new uses approved and 0 published complete response letters.
First approved: Mar 13, 2024
Applications: 2
New uses approved: 10
Complete response letters: 0
Medicare spending, 2025: $4.9M
Orphan exclusivity until: Mar 3, 2032
First approved in the EU: Sep 15, 2023
First approved in Japan: Mar 27, 2025
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 12 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Tevimbra, new ingredientA drug with a new active ingredient indicated for the treatment of unresectable advanced or recurrent esophageal cancer. · BeiGene Japan GK · Mar 27, 2025
Clinical Trials
2 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA