BeiGene Reports the US FDA approval for Tevimbra + CT as a 1L Treatment of Advanced ESCC
Shots:
- The US FDA approved Tevimbra (tislelizumab-jsgr) + Pt containing CT as 1L treatment in unresectable or metastatic esophageal squamous cell carcinoma (ESCC) adults whose tumors express PD-L1 (≥1)
- The approval was based on the P-III (RATIONALE-306) study (n=649) evaluating Tevimbra + CT vs. PBO + CT in unresectable, locally advanced recurrent, or metastatic ESCC pts. Study met its 1EP, demonstrating improved OS (mOS: 16.8mos. vs. 9.6mos.) and 34% reduction in death risk
- TEVIMBRA is IgG4 PD-1 mAb with high affinity and binding specificity against PD-1, already approved as a monotx. for unresectable or metastatic ESCC in adults after prior systemic CT without a PD-(L)1 inhibitor and in combination with CT for 1L treatment of G/GEJ cancer adults
Ref: BeiGene | Image: BeiGene
Related News:- BeiGene’s Tevimbra Plus Chemotherapy Secures the US FDA’s Approval as a 1L Treatment of G/GEJ Cancers
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