Sintilimab: First Global Approval.

Sintilimab (Tyvyt®) is a fully human IgG4 monoclonal antibody that binds to programmed cell death receptor-1 (PD-1), thereby blocking the interaction of PD-1 with its ligands (PD-L1 and PL-L2) and consequently helping to restore the endogenous antitumour T-cell response. It has been co-developed by Innovent Biologics and Eli Lilly and Company, and was recently approved in China for the treatment of classical Hodgkin's lymphoma in patients who have relapsed or are refractory after ≥ 2 lines of systemic chemotherapy. Sintilimab is undergoing phase I, II and III development for use in various solid tumours, including non-small cell lung cancer and oesophageal cancer, in China. Phase I/II development of sintilimab for use in solid tumours is underway in the USA, with the US FDA accepting an Investigational New Drug application for sintilimab in January 2018. This article summarizes the milestones in the development of sintilimab leading to this first approval for the treatment of classical Hodgkin's lymphoma in patients who have relapsed or are refractory after ≥ 2 lines of systemic chemotherapy.