BeiGene Receives FDA Approval for TEVIMBRA® for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior Chemotherapy
Retrieved on:
Thursday, March 14, 2024
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TEVIMBRA will be available in the U.S. in the second half of 2024.
Key Points:
- TEVIMBRA will be available in the U.S. in the second half of 2024.
- The FDA is also reviewing Biologics License Applications (BLAs) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC and patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
- BeiGene has launched more than 17 potentially registration-enabling trials with TEVIMBRA, of which 11 Phase 3 randomized trials and four Phase 2 trials have already had positive readouts.
- More than 900,000 patients have been prescribed TEVIMBRA globally to date.