Tevimbra® (tislelizumab-jsgr)

BL 761232 [BL 761417] [BL 761380]

Tevimbra® (tislelizumab-jsgr)

BL 761232 [BL 761417] [BL 761380]

U.S. License Holder:

BeiGene

Date of License:

March-13-2024 [December-26-2024] [March-03-2025]

Last Update:

June-15-2025

approved_indications FDA-Approved Indications

BL 761232: TEVIMBRA (tislelizumab-jsgr) is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.

BL 761417, BL 761380: TEVIMBRA (tislelizumab-jsgr) is a programmed death receptor-1 (PD-1)-blocking antibody indicated for:

Esophageal Cancer: 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); as a single agent in adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor;

Gastric Cancer: in combination with platinum and fluoropyrimidine-based chemotherapy in adults for the first line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (greater than or equal to 1).

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Methodology

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