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# BeiGen BLA for Anti-PD-1 Tislelizumab
- URL: https://www.fdaweb.com/beigen-bla-for-anti-pd-1-tislelizumab/
- Published: 2021-09-13T12:00:00.000Z
- Updated: 2026-09-14T17:14:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150132

FDA has accepted for review a BeiGene BLA for its anti-PD-1 antibody tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic therapy. The agency has set a user fee review action target date of 7/12/2022.

The submission is based on data from the RATIONALE 302, a randomized, open-label, multicenter global Phase 3 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, according to the company.

BeiGene describes tislelizumab as an IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcR on macrophages. “In pre-clinical studies, binding to FcR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells,” it says.