BeiGene (NASDAQ: BGNE) shares surged over 5% on Thursday as the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) recognized the favorable benefit-risk profile of the company's PD-1 inhibitor Tevimbra (tislelizumab-jsgr) as a potential first-line treatment for certain types of esophageal cancer.

Specifically, the ODAC's positive opinion applies to the use of PD-1 inhibitors, including Tevimbra, as a first-line treatment for patients with locally advanced inoperable or metastatic esophageal squamous cell carcinoma (ESCC) expressing specific cancer markers. The committee's conclusion was based on multiple studies evaluating the efficacy and safety of PD-1 inhibitors in this setting.

While Tevimbra has already been approved in the U.S. for the treatment of adults with unresectable or metastatic ESCC after prior chemotherapy, the ODAC's favorable opinion could potentially pave the way for an expanded label to include first-line use in the specified patient population. BeiGene's Biologics License Applications for Tevimbra remain under review by the FDA.