Shares of BeiGene (BGNE) surged 6% on Thursday after the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee recognized the "favorable benefit-risk profile" of PD-1 inhibitors like the company's Tevimbra cancer treatment.
The FDA advisory committee's conclusion applied to the use of PD-1 inhibitors as a first-line treatment for patients with locally advanced inoperable or metastatic esophageal squamous cell carcinoma expressing certain specific cancer markers. The positive assessment was based on several studies of PD-1 inhibitors, including BeiGene's Tevimbra (tislelizumab-jsgr).
While Tevimbra is already approved in the U.S. for treating unresectable or metastatic esophageal squamous cell carcinoma after prior chemotherapy, the FDA's favorable view on the drug class could boost the prospects of Tevimbra getting approved for additional indications. BeiGene said the Biologics License Applications for Tevimbra remain under FDA review.
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