By Stephen Nakrosis

BeiGene on Thursday said the Food and Drug Administration approved Tevimbra to treat certain adult patients with unresectable or metastatic esophageal squamous cell carcinoma, or ESSC.

The company said this was the first U.S. indication for Tevimbra, or tislelizumab-jsgr. The treatment will be available in the U.S. in the second half of this year, BeiGene said.

The FDA is reviewing biologics license applications 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 adenocarcinoma," BeiGene said.

Tislelizumab has been approved for certain patients with advanced or metastatic ESCC after prior chemotherapy. It received a positive opinion by the Committee for Medicinal Products for Human Use of the European Medicines Agency earlier this year to treat non-small cell lung cancer across three indications, the oncology company said.

Write to Stephen Nakrosis at

(END) Dow Jones Newswires

03-14-24 1722ET