05:03 PM EDT, 03/14/2024 (MT Newswires) -- BeiGene ( BGNE ) said late on Thursday that its treatment for adult patients with unresectable or metastatic esophageal squamous cell carcinoma received approval from the US Food and Drug Administration.

The company said the approval follows a trial that met its primary endpoint in the intention-to-treat population with a statistically significant and clinically meaningful survival benefit for tevimbra compared with chemotherapy.

The monotherapy -- tevimbra (tislelizumab-jsgr) -- is for patients who have had prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. It will be available in the US in H2, it said.

Tislelizumab received approval from the European Commission for advanced or metastatic ESCC in 2023 and a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in February 2024 as a treatment for non-small cell lung cancer across three indications.

Shares of the company were up 1% in after-hours activity.

Price: 170.72, Change: +1.82, Percent Change: +1.08