FDA Accepts BLA for Tislelizumab for Second-line Esophageal Cancer


The PDUFA date has been set for July 12, 2022.

The FDA has accepted the biologics license application (BLA) for the BeiGene’s anti-PD-1 antibody tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma after prior systemic therapy. The Prescription Drug User Fee Act (PDUFA) target action date is July 12, 2022.

In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

The submission is based on results from RATIONALE 302, a global phase 3 trial that evaluated the efficacy and safety of tislelizumab compared with investigator’s choice of chemotherapy as a second-line treatment for patients with advanced or metastatic ESCC. The trial demonstrated a 30% reduction in the risk of death and extended median overall survival by 2.3 months compared with chemotherapy in people with unresectable recurrent locally advanced or metastatic

Results of this trial were presented at the 2021 American Society of Clinical Oncology Annual Meeting (ASCO 2021). The submission also included safety data on 1,972 patients who received tislelizumab as a monotherapy from seven clinical trials.

The National Institutes of Health predicts there will be more than 19,000 new cases of esophageal cancer in 2021 and an estimated 15,530 deaths from this cancer.

There are two main types of esophageal cancer: squamous cell carcinoma (ESCC) and adenocarcinoma (EAC). Squamous cell carcinoma accounts for up to 30% of esophageal cancer cases in the United States. Five-year survival rate for this cancer is 19.9%.

In addition to the United States, tislelizumab is under regulatory review in China for this indication.

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