FDA accepts BLA for tislelizumab to treat esophageal squamous cell carcinoma.
The Prescription Drug User Fee Act (PDUFA) target action date is July 12, 2022.
The BLA submission is based on results from RATIONALE 302, a randomized, open-label, multicenter global Phase III trial (NCT03430843) designed to evaluate the efficacy and safety of tislelizumab when compared to investigator’s choice chemotherapy as a second-line treatment for patients with advanced or metastatic ESCC. 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. 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.