Novartis submit BLA for tislelizumab for oesophageal cancer treatment
US FDA have accepted Biologics License Application (BLA) for tislelizumab for the treatment of oesophageal squamous cell carcinoma cancer.
Novartis have announced that the US Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for anti-PD-1 immune checkpoint inhibitor tislelizumab for the treatment of unresectable recurrent locally advanced or metastatic oesophageal squamous cell carcinoma (ESCC) in people who had received prior systemic therapy.
Tislelizumab is a humanised immunoglobulin G4 (IgG4) anti-PD-1 monoclonal antibody specifically designed to minimise binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumour activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. The clinical impact of these features is not yet known.
The BLA submission was based on data from the Phase III RATIONALE 302 trial, which demonstrated a 30 percent reduction in the risk of death and extended median overall survival by 2.3 months compared to chemotherapy in people with unresectable recurrent locally advanced or metastatic ESCC who had received prior systemic therapy.
BeiGene filed the BLA on behalf of Novartis in the US for tislelizumab for the treatment of unresectable recurrent locally advanced or metastatic ESCC in people who had received prior systemic therapy. In an agreement finalised earlier this year, BeiGene granted Novartis rights to develop, manufacture and commercialise tislelizumab in North America, Europe, and Japan through a collaboration and license agreement.
“This is an encouraging step forward in our mission to deliver transformative therapies for people living with cancer, and especially for people with oesophageal cancer, an aggressive disease with limited treatment options,” stated Jeff Legos, Executive Vice President, Global Head of Oncology & Haematology Development at Novartis. “We are advancing tislelizumab as a key cornerstone of our immunotherapy program and PD-1 backbone for combination therapy. We will work with regulatory authorities to ensure it is available for people with oesophageal cancer as soon as possible.”