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With First US Approval, BeiGene’s Tevimbra To Start Small, Work Its Way Up

 
• By Alaric DeArment

The FDA approved the PD-1 inhibitor for previously treated esophageal cancer, while BeiGene anticipates decisions on first-line ESCC as well as G/GEJ cancer later in the year.

• Source: Shutterstock

BeiGene, Ltd.’s initial US Food and Drug Administration approval of Tevimbra (tislelizumab) for a relatively small esophageal cancer indication offers a foot in the regulatory and commercial door before the company brings it into a much wider array of cancers affecting the esophagus, which could happen before the end of the year.

The drug maker announced FDA approval on 15 March for Tevimbra to treat esophageal squamous cell carcinoma (ESCC) as a monotherapy in patients with unresectable or metastatic disease after prior systemic chemotherapy that does not include a PD-1/L1 inhibitor, with plans to launch the drug in the second half of the year

Key Takeaways

  • The FDA approved BeiGene’s PD-1 inhibitor, Tevimbra, as a monotherapy for esophageal squamous cell carcinoma (ESCC) in patients with previously treated disease.

  • The company plans to launch the drug in the second half of 2024. In the meantime, it expects FDA decisions on first-line ESCC as well as gastric or gastroesophageal junction later this year

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