Envafolimab: First Approval

Envafolimab ((sic)(sic)(R)) is a subcutaneously (SC) administered single domain anti-programmed death ligand 1 (PD-L1) antibody being developed for the treatment of various solid tumours and chronic hepatitis B in China, and for soft tissue sarcomas and biliary tract cancer in the USA. Single-domain antibodies are more soluble and more rapidly penetrate tissues than full monoclonal antibodies, enabling SC administration. Based on the results of a pivotal phase II trial, SC envafolimab was recently approved in China for the treatment of adult patients with previously-treated microsatellite instability-high (MSI-H) or deficient MisMatch Repair (dMMR) advanced solid tumours. This article summarizes the milestones in the development of envafolimab leading to this first approval.

Automated summary

Envafolimab, a subcutaneously administered single domain anti-PD-L1 antibody, has recently been approved in China for the treatment of various solid tumors and chronic hepatitis B. It has better solubility and tissue penetration than full monoclonal antibodies, allowing for subcutaneous administration.