Loncastuximab tesirine is approved under accelerated approval based on overall response rate. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Loncastuximab tesirine is a CD19-directed antibody and alkylating agent conjugate consisting of a humanized IgG1 kappa monoclonal antibody conjugated to SG3199, a pyrrolobenzodiazepine dimer cytotoxic alkylating agent, through a protease-cleavable valine-alanine linker. Treatment-emergent adverse events considered likely to be related to the pyrrolobenzodiazepine moiety include pleural effusion, adverse skin reactions and elevated liver enzymes.
Loncastuximab tesirine-lpvl is biosimiar