FDA Accepts BeiGene’s BLA for Tislelizumab in Esophageal Squamous Cell Carcinoma

On September 13, 2021 BeiGene announced the FDA’s acceptance of its BLA for tislelizumab in esophageal squamous cell carcinoma (ESCC).  While tislelizumab is already approved for five indications in China, this marks the first ex-China regulatory filing for the biologic.  The BLA was filed in collaboration with Novartis and is supported by the Phase 3 RATIONALE 302 trial.  As Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene stated, “Our uniquely designed anti-PD-1 antibody tislelizumab has been shown to significantly improve survival compared to chemotherapy for people with a variety of solid tumors and hematologic malignancies. We previously shared the compelling results at ASCO 2021 with tislelizumab significantly prolonging survival and demonstrating a favorable safety profile over chemotherapy in patients with locally advanced or metastatic ESCC, a devastating disease with an average five-year survival rate of just five percent.  This BLA acceptance brings us closer to potentially providing tislelizumab as a treatment for these patients in the United States.”  Tislelizumab is also currently 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.