BeiGene (BGNE) shares were up 3.5% in Friday's premarket activity after it said that the US Food and Drug Administration's Oncologic Drugs Advisory Committee had recognized the "favorable benefit-risk profile" of PD-1 inhibitors such as the company's Tevimbra as a first-line treatment for patients with locally advanced inoperable or metastatic esophageal squamous cell carcinoma.
The conclusion by the advisory applied to esophageal squamous cell carcinoma expressing certain specific cancer markers, the company said. It was based on several studies of PD-1 inhibitors, including Tevimbra, also called tislelizumab-jsgr.
The company said the Biologics License Applications for Tevimbra remain under FDA review. The drug has already been approved in the US for the treatment of adults with unresectable or metastatic ESCC after prior chemotherapy treatments.
Price: 220.01, Change: +7.48, Percent Change: +3.52
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