BeiGene and Novartis Report the US FDA’s Acceptance of BLA for Tislelizumab to Treat Esophageal Squamous Cell Carcinoma

September 13, 2021 Auto Bot BeiGene, BLA, FDA, regulatory, Tislelizumab 0

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

Click here to read full press release/ article | Ref: Novartis | Image: The Economist

The post BeiGene and Novartis Report the US FDA’s Acceptance of BLA for Tislelizumab to Treat Esophageal Squamous Cell Carcinoma first appeared on PharmaShots.