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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: tislelizumab-jsgr
Trade Name: Tevimbra
Date Designated: 11/06/2019
Orphan Designation: Treatment of Esophageal Cancer
Orphan Designation Status: Designated/Approved
BeOne Medicines USA, Inc.
311 Pennington-Rocky Hill Rd., Bldg 51-Ste 1358
Pennington, New Jersey 08534
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: tislelizumab-jsgr
Trade Name: Tevimbra
Marketing Approval Date: 03/13/2024
Approved Labeled Indication: as a single agent, for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor
Exclusivity End Date: 03/13/2031 
Exclusivity Protected Indication* :  treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor
2 Generic Name: tislelizumab-jsgr
Trade Name: Tevimbra
Marketing Approval Date: 03/03/2025
Approved Labeled Indication: in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (greater than or equal to 1)
Exclusivity End Date: TBD  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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