FDA Approves Tevimbra for the Treatment of Advanced or Metastatic Esophageal
Squamous Cell Carcinoma
BeiGene, Ltd., has announced that the U.S. Food and Drug Administration (FDA) has approved Tevimbra (tislelizumab-jsgr) as monotherapy 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.
Approval is based on the RATIONALE 302 trial, which met its primary endpoint in the intention-to-treat (ITT) population with a statistically significant and clinically meaningful survival benefit for Tevimbra compared with chemotherapy, highlighting its potential as an important treatment option for these patients.
Tevimbra is an IV injection and will be available in the U.S. in the second half of 2024.
