TEVIMBRA

批准信原文要点

This Prior Approval sBLA provides a new indication for TEVIMBRA in combination with zanidatamab-hrii and fluoropyrimidine- and platinum-containing chemotherapy for the first line treatment of adults with HER2-positive (IHC 3+ or IHC2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-authorized test, to the United States Prescribing Information (USPI).

批准信原文要点

This Prior Approval supplemental biologics license application provides a new dosing regimen for Tevimbra (tislelizumab-jsgr) of 400 mg intravenous infusion every 6 weeks, in combination with platinum-containing chemotherapy for the first-line treatment of unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PDL1 (≥1).

批准信原文要点

This Prior Approval supplemental biologics license application provides a new dosing regimen for Tevimbra (tislelizumab-jsgr) of 400 mg intravenous infusion once every 6 weeks in combination with platinum and fluoropyrimidine-based chemotherapy for the first line treatment of adults with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) whose tumors express PD-L1 (≥1).

批准信原文要点

This Prior Approval supplemental biologics license application provides a new dosing regimen for Tevimbra (tislelizumab-jsgr) of 400 mg intravenous infusion every 6 weeks 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.

批准信原文要点

Tevimbra, as a single agent, is indicated 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.

批准信原文要点

This Prior Approval supplemental biologics application provides updates (updated pooled tislelizumab monotherapy safety data) to Sections 5 and 6 of the Tevimbra (tislelizumab-jsgr) U.S. prescribing information (USPI).

批准信原文要点

This Prior Approval supplemental biologics license application provides a new dosing regimen for Tevimbra (tislelizumab-jsgr) of 300 mg intravenous infusion administered once every 4 weeks, 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 (≥1).

批准信原文要点

This Prior Approval supplemental biologics license application provides a new dosing regimen for Tevimbra (tislelizumab-jsgr) of 150mg intravenous infusion administered once every 2 weeks, 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 (≥1).

批准信原文要点

This Prior Approval supplemental biologics license application provides a new dosing regimen for Tevimbra (tislelizumab-jsgr) of 300 mg intravenous infusion administered every 4 weeks, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adults with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) whose tumors express PD-L1 (≥1).

批准信原文要点

This Prior Approval supplemental biologics license application provides a new dosing regimen for Tevimbra (tislelizumab-jsgr) of 150 mg intravenous infusion administered once every 2 weeks, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adults with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) whose tumors express PD-L1 (≥1)

批准信原文要点

This Prior Approval supplemental biologics license application provides a new dosing regimen for Tevimbra (tislelizumab-jsgr) of 300 mg intravenous infusion administered every 4 weeks, 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.

批准信原文要点

This Prior Approval supplemental biologics license application provides a new dosing regimen for Tevimbra (tislelizumab- jsgr) of 150 mg intravenous infusion administered once every 2 weeks, 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.