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

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.

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...

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...