Shots:

• The BLA submission is based on a P-III RATIONALE 302 trial evaluating the efficacy and safety of tislelizumab vs CT in 1972 patients with advanced or metastatic ESCC who had received prior systemic therapy. The anticipated PDUFA date for the therapy is July 12- 2022
• The trial met its 1EPs i.e.- the therapy showed a 30% reduction in the risk of death and extended m-OS (2.3mos.)
• Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 mAb- designed to minimize binding to FcγR on macrophages & is currently under regulatory review in China. In Jan’21- Novartis gets the rights to develop- manufacture & commercialize tislelizumab in the EU- North America & Japan

   Ref: Novartis | Image: Novartis