The US FDA Grants Approval to BeiGene’s Tevimbra to Treat Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Shots:
- BeiGene’s Tevimbra has received the US FDA’s approval as a monotx. to treat unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after previous systemic chemotherapy (CT) excl. PD-(L)1 inhibitor. The US availability is anticipated in H2’24
- The approval was supported by the P-III (RATIONALE 302) study assessing the safety & efficacy of Tevimbra vs CT for the 2L treatment of unresectable, locally advanced or metastatic ESCC patients (n=512) across the EU, Asia & North America
- The study met the 1EP among the ITT population demonstrating mOS of 8.6mos. vs 6.3mos. with a favorable safety outcome
Ref: BeiGene | Image: BeiGene
Related News:- BeiGene’s Tevimbra (tislelizumab) Receives CHMP’s Positive Opinion for the Treatment of Non-Small Cell Lung Cancer (NSCLC)
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
