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BeiGene : FDA Accepts BLA For Tislelizumab In Esophageal Squamous Cell Carcinoma

BeiGene Ltd. (BGNE) said Monday that the U.S. Food and Drug Administration accepted for review a Biologics License Application or BLA for its anti-PD-1 antibody tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma or ESCC after prior systemic therapy.

The Prescription Drug User Fee Act (PDUFA) target action date is July 12, 2022.

The accepted BLA, filed in collaboration with Novartis, is supported by the positive global Phase 3 RATIONALE 302 trial in patients with previously treated, advanced or metastatic ESCC and safety data from tislelizumab's broad clinical program, BeiGene said in a statement.

In addition to the United States, tislelizumab is also under regulatory review in China as a treatment for patients with locally advanced or metastatic ESCC who have disease progression following or are intolerant to first-line standard chemotherapy.

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